Expandable introducer sheath to preserve guidewire access

ABSTRACT

An introducer sheath is described. The introducer sheath may include a tubular body. The tubular body may extend from a distal end toward a proximal end. The tubular body may include a lumen. The lumen may at least partially be defined by a wall. A channel may be disposed within the wall. The channel may be configured to receive a guidewire. The tubular body may include an expandable portion expandable to increase a cross-sectional area of the lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/696,792, filed Jan. 29, 2010, which is a continuation-inpart of U.S. patent application Ser. No. 11/767,947, filed Jun. 25,2007, which is a continuation-in-part of U.S. patent application Ser.No. 11/427,308, filed Jun. 28, 2006. This application is acontinuation-in-part of U.S. patent application Ser. No. 11/767,947,filed Jun. 25, 2007, which is a continuation-in-part of U.S. patentapplication Ser. No. 11/427,308, filed Jun. 28, 2006. This applicationis a continuation-in-part of U.S. patent application Ser. No.12/696,837, filed Jan. 29, 2010, which is a continuation-in-part of U.S.patent application Ser. No. 11/427,308, filed Jun. 28, 2006. Thisapplication is a continuation-in-part of U.S. patent application Ser.No. 11/427,308, filed Jun. 28, 2006. The entireties of which are eachhereby incorporated by reference.

This application relates to U.S. patent application Ser. No. 11/427,301,entitled “Modular Introducer and Exchange Sheath”, and filed Jun. 28,2006 and U.S. patent application Ser. No. 11/427,306, entitled“Introducer Sheath”, and filed Jun. 28, 2006, each of which areincorporated herein by reference in its entirety.

This application also incorporates by reference U.S. patent applicationSer. No. 10/356,214, U.S. patent application Ser. No. 10/638,115, andU.S. Provisional Patent Application Ser. No. 60/696,069 in theirentireties.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to medical devices and methods.More particularly, embodiments of the invention relate to expandablemedical devices, such as introducer sheaths, for use during medicalprocedures.

2. The Relevant Technology

A wide variety of devices have been developed for medical use. One suchdevice is an introducer sheath that facilitates access to body lumen atan access site. Conventionally, introducer sheaths are formed of threeor more components that require assembly: a sheath portion, a hub, and ahemostasis valve disposed within the hub. A suitable example of such anassembly is shown in U.S. Pat. No. 5,807,350, which depicts anintroducer sheath having a construction similar to that described above,the entirety of which is hereby incorporated by reference.

In practice, introducer sheaths are often used to access a vessel orartery to allow a surgical or medical procedure to be performed. Theintroducer sheath is generally inserted into a patient's vasculatureusing the modified Seldinger technique. In the Seldinger technique, aneedle is first inserted into the vessel and then followed by aguidewire through the needle. Next, the needle is removed and asheath/dilator combination is advanced over the guidewire. Thesheath/dilator expands the puncture in the vessel to a size suitable toreceive the distal end of an introducer sheath. After the distal end ofthe sheath is disposed within the vessel, the dilator and guidewire areremoved, thereby allowing access to the vessel lumen through theintroducer sheath.

There are an increasing number of medical procedures that can beperformed using sheaths. Medical procedures such as angioplasty,stenting, and intraaortic therapy, are examples of procedures that caninclude the use of introducer sheaths. In particular, the medicaldevices (e.g., catheters, balloon pumps) used in these procedures areintroduced through the sheath.

Some of these procedures unfortunately require removal of the sheathearlier than desired. For example, intraaortic balloon pump therapy forventricular insufficiency is often performed using a sheath. In thisprocedure, a sheath may be inserted into the femoral artery. Next, aballoon pump may be introduced into the patient's vasculature throughthe sheath and then guided to the aortic arch region. Once the balloonpump is properly positioned in the arch region, it is typically left inplace until the ventricular insufficiency is improved to an acceptablelevel, which may take days.

In this procedure, the balloon pump may be inflated and deflated at arate that typically matches the heart rate. Thus, the balloon pump isusually inflated during ventricular diastole and deflated duringventricular systole. Because of the use of the balloon pump for theintraaortic therapy, the balloon pump may be larger compared to when itwas initially inserted through the sheath. Because of the increasedsize, removal of the balloon pump also requires the removal of thesheath since the enlarged balloon pump typically cannot fit inside ofthe sheath tubing. One of the disadvantages of removing the sheath alongwith the balloon pump is that the opportunity to close the vessel withany vessel closure device through the sheath may be lost.

Furthermore, the user typically removes the guidewire from the patient'sbody lumen in order to deploy the closure element. However, many usersmay wish to have guidewire access in case the need arises to re-accessthe site or if other complications arise upon closing. Thus, it may bedesirable to deploy a guidewire into the body lumen in such a way thatit does not interfere with the introduction of the closure element.

There is therefore a need for a new introducer sheath to accommodateremoval and/or insertion of devices that change in size or that do notwork with conventional sheaths. It may also be desirable to provideguidewire access in such a way that a closure element may also beintroduced.

BRIEF SUMMARY OF THE INVENTION

These and other limitations are overcome by embodiments of thedisclosure, which relates to medical devices and in particular toexpandable introducer sheaths. Embodiments of the disclosure provideseveral designs and methods of manufacture of an expandable introducersheath. One embodiment is an introducer sheath formed as a unitarydevice using, for example, and injection molding process or aco-extrusion process.

In one configuration of an expandable introducer sheath, one or morematerials are used to form the sheath. At least one of the materialsprovides elasticity. The elasticity enables the sheath to expand,thereby accommodating the introduction and/or removal of medical devicesthat could not previously be accommodated.

In one configuration, the introducer sheath includes a hub portion and atubular portion. A valve member (such as a hemostasis valve) can bedisposed into the hub portion either during the molding process or afterthe initial molding process. The hemostasis valve can be retained eitherby an additional element such as a cap or through an element formedduring the molding process or during a subsequent molding process.

The tubular portion can include a sheath portion and an elastic portion,which can be formed as a unitary portion through injection molding orco-extrusion processes, for example. The elastic portion of the sheathmay be an elastomer that is integrated with another material in thesheath portion that provides rigidity and/or prevents a lumen of thetubular portion from collapsing. When a medical device is withdrawn, forexample, the elastic portion can expand thereby permitting the medicaldevice to be withdrawn without splitting the introducer sheath.Advantageously, this enables the use of a subsequent medical device,such as a vessel closure device, to be introduced through the intactsheath, whether or not the vessel closure device splits or cuts theintroducer sheath during use. An embodiment of an introducer sheath isdescribed. The introducer sheath includes a tubular body extending froma distal end toward a proximal end. The tubular body includes a lumendefined at least partially by a wall. The tubular body includes achannel disposed within the wall and configured to receive a guidewire.The tubular body includes an expandable divider expandable to increase across-sectional area of the lumen.

In some embodiments, the expandable divider is located between the lumenand the channel. The expandable divider, in further embodiments,includes a first end connected to the wall and a second end connected tothe wall. In still further embodiments, a first linear length is definedfrom the first end of the expandable divider toward the second end ofthe expandable divider. A first curve length, in yet furtherembodiments, is defined from the first end of the expandable dividertoward the second end of the expandable divider along a curve defined bythe expandable divider.

In some embodiments, the first curve length is larger than the firstlinear length. The first curve length, in further embodiments, is aboutfifty percent larger than the first linear length. In still furtherembodiments, the expandable divider elastically deforms when theexpandable divider expands beyond a predetermined diameter and/or apredetermined expansion distance. The expandable divider, in yet furtherembodiments, plastically deforms when the expandable divider expandsbeyond a predetermined diameter and/or a predetermined expansiondistance.

The tubular body, in some embodiments, includes an entry portion at thedistal end that facilitates entry of a medical device. In furtherembodiments, the tubular body is configured to expand to accommodate themedical device without splitting an outer surface of the tubular body.The expandable divider, in still further embodiments, is in a shapeselected from the group consisting essentially of a sinusoidal shape, aconcertina shape, an overlapping shape, a serpentine shape, orcombinations thereof.

In some embodiments, the expandable divider is expandable from apre-expanded state where the lumen has a pre-expanded dimension to anexpanded state where the lumen has an expanded dimension before the wallof the lumen deforms. The pre-expanded dimension, in furtherembodiments, is a diameter of about eight French in a pre-expandedstate. In still further embodiments, the pre-expanded dimension is adiameter of about ten French in an expanded state.

Another embodiment of an introducer sheath is described. The introducersheath includes a hub portion extending from a distal end toward aproximal end having a hub lumen formed therein. The introducer sheathincludes a tubular body extending from a distal end toward a proximalend. The tubular body includes a lumen defined at least partially by awall. The tubular body includes a channel disposed within the wall andconfigured to receive a guidewire. The tubular body includes anexpandable divider expandable to increase a cross-sectional area of thelumen.

In some embodiments, the expandable divider is located between the lumenand the channel. The expandable divider, in further embodiments,includes a first end connected to the wall and a second end connected tothe wall. A first linear length, in still further embodiments, isdefined from the first end of the expandable divider toward the secondend of the expandable divider and a first curve length is defined fromthe first end of the expandable divider toward the second end of theexpandable divider along a curve defined by the expandable divider.

The first curve length, in some embodiments, is larger than the firstlinear length. In further embodiments, the expandable dividerelastically deforms when the expandable divider expands beyond apredetermined diameter and/or a predetermined expansion distance. Instill further embodiments, the tubular body includes an entry portion atthe distal end that facilitates entry of a medical device. The tubularbody, in yet further embodiments, is configured to expand to accommodatethe medical device without splitting an outer surface of the tubularbody. The expandable divider, in even further embodiments, is in a shapeselected from the group consisting essentially of a sinusoidal shape, aconcertina shape, an overlapping shape, a serpentine shape, orcombinations thereof.

An embodiment of a method for introducing a medical device into a bodyis described. The method includes positioning a sheath upon a guidewiredisposed within a body lumen. The sheath includes a tubular bodyextending from a distal end toward a proximal end. The tubular bodyincludes a lumen defined at least partially by a wall. The tubular bodyincludes a channel disposed within the wall and configured to receivethe guidewire. The tubular body includes an expandable dividerexpandable to increase a cross-sectional area of the lumen. The methodincludes introducing the sheath into the body lumen. A first medicaldevice is selectively inserted into the body lumen through the sheath.

In some embodiments, the expandable divider is located between the lumenand the channel. The expandable divider, in further embodiments,includes a first end connected to the wall and a second end connected tothe wall. In still further embodiments, a first linear length is definedfrom the first end of the expandable divider toward the second end ofthe expandable divider and a first curve length is defined from thefirst end of the expandable divider toward the second end of theexpandable divider along a curve defined by the expandable divider. Thefirst curve length being larger than the first linear length, in yetfurther embodiments.

The tubular body, in some embodiments, includes an entry portion at thedistal end that facilitates entry of a medical device. In furtherembodiments, the tubular body is configured to expand to accommodate themedical device without splitting an outer surface of the tubular body.The expandable divider, in still further embodiments, is in a shapeselected from the group consisting essentially of a sinusoidal shape, aconcertina shape, an overlapping shape, a serpentine shape, orcombinations thereof.

In some embodiments, the expandable divider is expandable from apre-expanded state where the lumen has a pre-expanded dimension to anexpanded state where the lumen has an expanded dimension before the wallof the lumen deforms. A second medical device, in further embodiments,is selectively inserted into the body lumen through the sheath.

An embodiment of an introducer sheath is described. The introducersheath includes a tubular body. The tubular body extending from a distalend toward a proximal end. The tubular body includes a lumen defined atleast partially by a wall. The lumen also includes a secondary channeldisposed within the wall and configured to receive a guidewire.

Another embodiment of an introducer sheath is described. The introducersheath includes a hub portion that extends from a distal end toward aproximal end. The hub portion includes a hub lumen formed therein. Theintroducer sheath includes a tubular body extending from a distal endtoward a proximal end. The tubular body includes a lumen defined atleast partially by a wall. The introducer sheath includes a secondarychannel disposed within the wall. The secondary channel is configured toreceive a guidewire. The introducer sheath includes a portion ofweakened structural integrity. The portion of weakened structuralintegrity is located between the lumen and the secondary channel. Theportion of weakened structural integrity splits when the body expandsbeyond a predetermined diameter and/or a predetermined expansiondistance to increase a cross-sectional area of the tubular body.

In some embodiments, the tubular body includes at least one deformableexpandable portion configured to increase a cross-sectional area of thetubular body. In further embodiments, the deformable expandable portionsplits when the deformable expandable portion expands beyond apredetermined diameter and/or a predetermined expansion distance. Aportion of the tubular body, in still further embodiments, splits whenexpanded beyond a predetermined diameter and/or a predeterminedexpansion distance. At least one deformable expandable portion, in someembodiments, is located between the lumen and the secondary channel.

The tubular body, in some embodiments, includes a geometric patternformed on at least a portion of an inner wall of the tubular body tofacilitate splitting a portion of the tubular body. In some embodiments,the geometric pattern, includes a groove that facilitates splitting ofat least a portion of the tubular body, a groove that facilitatessplitting of at least the deformable expandable portion, a separationline to facilitate splitting of at least a portion of the tubular body,a separation line to facilitate splitting of at least the deformableexpandable portion, a plurality of grooves running parallel to alongitudinal axis of the tubular body, and/or a plurality of groovesthat are not parallel to the longitudinal axis.

In some embodiments, at least one deformable expandable portion includesan elastic portion comprising a first material including an elastomerand the tubular body further includes at least one sheath portioncomprising a second material. In further embodiments, the at least oneelastic portions comprise a plurality of strips and the at least onesheath portions comprise a plurality of strips, each strip of theelastic portion being bonded to at least one adjacent strip of thesheath portion. In still further embodiments, each strip of the at leastone elastic portion includes an interlocking feature to attach with atleast one adjacent strip of the sheath portion.

The tubular body, in some embodiments, includes an entry portion at thedistal end. The entry portion facilitates entry of a medical device, infurther embodiments. The tubular body, in still further embodiments, isconfigured to expand to accommodate the medical device without splittingan outer surface of the tubular body.

At least one of the deformable expandable portions, in some embodiments,includes a plurality of lumens formed in a wall of the deformableexpandable portion. In these embodiments, the plurality of lumensprovide elasticity to the deformable expandable portion.

An embodiment method for introducing a medical device into a body isdescribed. A sheath is positioned upon a guidewire disposed within abody lumen. The sheath includes a tubular body extending from a distalend toward a proximal end. The tubular body includes a lumen defined atleast partially by a wall. A secondary channel is disposed within thewall and configured to receive the guidewire. At least one deformableexpandable portion is configured to increase a cross-sectional area ofthe tubular body. The sheath is introduced into the body lumen. One ormore medical devices are selectively inserted into the body lumenthrough the sheath. In some embodiments, one of the at least onedeformable expandable portions is located near an inner wall of thelumen and/or on an inner wall of the secondary channel.

In some embodiments, the introducer sheath may include a fluid portassociated with the hub portion to facilitate the introduction orremoval of fluid from vasculature. The fluid port, in furtherembodiments, may include an alignment mechanism that aligns a medicaldevice introduced through the sheath.

The hub portion, in some embodiments, may include a valve member thatseals the hub portion. In further embodiments, the valve member mayinclude an elastomeric body having at least one slit formed therein toallow selective insertion and removal of a medical device whilemaintaining a fluid tight seal around the medical device.

In some embodiments, the distal end of the hub portion may include atransition from the distal end of the hub portion to the proximal end ofat least one of the tubular inner portion and the tubular outer portion.The introducer sheath, in further embodiments, may include a strainrelief at the transition. In still further embodiments, the tubularportion may include a tapered end formed at the distal end of thetubular member.

An embodiment of a method for manufacturing an introducer sheath isdescribed. The method includes forming an inner portion of a tubularportion. The tubular portion extends between a proximal end and a distalend. The inner portion defines a lumen. The method includes forming anouter portion around the inner portion. The outer portion encloses lessthan the entirety of the outer surface of the inner portion between theproximal end and the distal end.

In some embodiments, the first material may include expandable PTFE. Themethod, in further embodiments, may include forming a hub portion havinga lumen formed therein extending from at least one of the tubular innerportion and the tubular outer portion. In still further embodiments,forming the inner portion, the outer portion, the hub portion, orcombinations thereof may include using an injection molding process, anovermolding process, an extrusion process, a co-extrusion process, abump extrusion process, other processes, or combinations thereof. Thehub portion and at least one of the tubular inner portion and thetubular outer portion, in yet further embodiments, may be formed as aunitary member.

An embodiment of a method for performing a medical procedure isdescribed. The method includes introducing a sheath into a lumen of apatient. The sheath has a first unexpanded dimension. The methodincludes inserting a first medical device having an outer dimension intothe lumen through the sheath to perform a medical procedure. At least atubular member of the sheath expands to a second expanded dimension toaccommodate the outer dimension of the first medical device.

In some embodiments, the method may include inserting a second medicaldevice through the sheath. Inserting a second medical device through thesheath, in further embodiments, may include introducing a vessel closuredevice through the sheath and/or closing the lumen of the patient withthe vessel closure device. In still further embodiments, The sheath mayinclude a tubular portion extending from the hub portion. The tubularportion, in yet further embodiments, may include at least one elasticportion elastically deformable to increase a cross sectional area of thetubular portion.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the above-recited and other advantagesand features of the invention are obtained, a more particulardescription of the invention briefly described above will be rendered byreference to specific embodiments thereof which are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be consideredlimiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1A illustrates an assembly view of the components of one embodimentaccording to the present invention for closing openings in blood vesselwalls.

FIG. 1B illustrates another assembly view of the components of oneembodiment according to the present invention for closing openings inblood vessel walls.

FIG. 2 illustrates the assembled carrier assembly and triggeringassembly of the apparatus shown in FIGS. 1A and 1B.

FIG. 3A illustrates a close-up view of the proximal end of the apparatusshown in FIG. 2.

FIG. 3B illustrates a close-up view of the distal end of the apparatusshown in FIG. 2 in an unexpanded state.

FIG. 3C illustrates a close-up view of the distal end of the apparatusshown in FIG. 2 in an expanded state.

FIG. 4 illustrates the apparatus of FIG. 2 after distal advancement ofthe locator assembly, the triggering system and the carrier assembly.

FIG. 5 illustrates a close-up view of the triggering system and carrierassembly of the apparatus shown in FIG. 4.

FIG. 6 illustrates the apparatus of FIG. 1A-1B after the clip has beenreleased to close the opening in the tissue.

FIG. 7 illustrates a close-up view of the triggering system and carrierassembly of the apparatus of FIG. 1A-1B after the clip has been releasedto close the opening in the tissue.

FIG. 8 illustrates a cross-sectional schematic view of the distal end ofthe apparatus shown in FIG. 4 as assembled for deployment.

FIG. 9 illustrates a plan view of an alternative embodiment of anapparatus for closing openings in tissue in accordance with the presentinvention.

FIG. 10 illustrates a portion of a housing half of the alternativeembodiment of FIG. 9, illustrating the functional components thereof.

FIG. 11A illustrates a portion of a housing half of the alternativeembodiment of FIG. 9, without certain functional components.

FIG. 11B illustrates a portion of a locator control system of thealternative embodiment of FIG. 9.

FIG. 11C illustrates a portion of a locator release system of thealternative embodiment of FIG. 9.

FIG. 11D illustrates a side view of a plunger of the locator controlsystem of FIG. 11B of the alternative embodiment of FIG. 9.

FIG. 11E illustrates a perspective view of a tubular body block of thelocator control system of FIG. 11B of the alternative embodiment of FIG.9.

FIG. 11F illustrates a perspective view of a spring retainer of thelocator control system of FIG. 11B of the alternative embodiment of FIG.9.

FIG. 12 illustrates a close-up cross-sectional view of the proximal endof the apparatus shown in FIG. 9, illustrating the initial position ofthe locator control system.

FIG. 13 illustrates a close-up cross-sectional view of the proximal endof the apparatus shown in FIG. 9, illustrating the final position beforeclip release of the locator control system.

FIGS. 14A-14G illustrate various embodiments of closure elements thatcan be utilized with the apparatus of the present invention.

FIGS. 15A-K illustrate various steps in the deployment of embodiments ofthe present invention.

FIGS. 16A-16B illustrate various embodiments of a sheath containing asecondary channel for the introduction of a second guidewire.

FIG. 17 is a plan view of an exemplary embodiment of an introducersheath in accordance with the present invention;

FIG. 18 illustrates a cross-sectional view of one embodiment of theintroducer sheath in FIG. 17;

FIG. 19 illustrates a cross-sectional view of another embodiment of theintroducer sheath in FIG. 17;

FIG. 20 illustrates a cross-sectional view of yet another embodiment ofthe introducer sheath in FIG. 17;

FIG. 21 illustrates a cross-sectional view of another embodiment of theintroducer sheath in FIG. 17;

FIG. 22A illustrates an introducer sheath prior to insertion of amedical device;

FIG. 22B illustrates an introducer sheath prior to removal of a medicaldevice that has changed size during use;

FIG. 22C illustrates an embodiment of the introducer sheath duringremoval of the medical device that has changed size during use; and

FIG. 22D illustrates the use of a vessel closure device that isintroduced through the sheath after the medical device illustrated inFIGS. 6A and 6B has been withdrawn.

FIGS. 23-26 illustrate cross-sections of various embodiments of atubular body of an introducer sheath.

FIGS. 27A-29B illustrate cross-sections of further embodiments of atubular body of an introducer sheath.

FIG. 30 illustrates a perspective view of an embodiment of an introducersheath.

FIG. 31 illustrates a cross-sectional view of the tubular portion of theintroducer sheath of FIG. 30 along line 31-31 of FIG. 30 in anunexpanded state.

FIG. 32 illustrates a cross-sectional view of the tubular portion of theintroducer sheath along line 31-31 of FIG. 30 in an expanded state.

FIG. 33 illustrates a cross-sectional view of another embodiment of anintroducer sheath in an unexpanded state.

FIG. 34 illustrates a perspective view of a further embodiment of anintroducer sheath.

FIG. 35 illustrates a perspective view of yet another embodiment of anintroducer sheath.

DETAILED DESCRIPTION

Embodiments of the invention relate to a device that is expandable tocooperate with medical devices. In some embodiments, the device may beexpandable to cooperate with medical devices that may have a largerdimension and/or may become enlarged in dimension during use. Forinstance, in one configuration, the device can be an expandableintroducer sheath that can accommodate removal of enlarged medicaldevices without removing the introducer from the delivery site. In otherembodiments, the device may be expandable to cooperate with medicaldevices that are too large to be inserted and/or removed prior to use.For example, the medical device may have a larger measurement, i.e.diameter, width, etc., than a measurement of the device.

As such, the sheath or at least a portion of the introducer sheath canexpand to accommodate the introduction and/or removal of medical devicesthat could not ordinarily be accommodated in conventional sheaths. Atthe same time, the sheath can be formed to have desirable stiffness,kink resistance, and/or flexibility for insertion and positioning in atleast a portion of a body lumen. Embodiments of the sheath are depictedin the drawings, which are not necessarily to scale and are not intendedto limit the scope of the invention. It will be understood that thebenefits of the present invention are not limited to application with anintroducer sheath. Rather, other medical devices may be modified basedupon the teaching contained herein such that they to can provide thefunctionality of accommodating removal of enlarged medical devices.

In one configuration, an expandable portion is provided that may have acurve length that is longer than a linear length between a first and asecond end. In use, the expandable portion may be deflected from a lumentoward a secondary channel to accommodate a device of larger size.

Turning to the introducer sheath in accordance with the presentinvention, the sheath will be described herein as having portions ormembers, though it shall be understood that the sheath as describedherein can be formed as a unitary unit, formed, by way of example, usinga co-extrusion process or an injection molding process, or a sheathfabricated from the assembly of separate parts. As such, the variousmembers or portions are used herein for clarification only and in no waylimit the applicability of description herein to other configurations ofthe sheath and/or medical devices.

Generally stated, an exemplary introducer sheath can include a hubmember or portion having a proximal end and a distal end. The proximalend of the sheath can be configured to receive a flexible valve membertherein. The sheath can further include an elongated tubular member orportion generally extending from the distal portion of the hub portion.The elongated tubular body, in one configuration, can be generallyaxially aligned with an axis of the hub portion, with the lumen of thetubular body being aligned with a lumen of the hub portion.Alternatively, the lumen of the tubular body can be aligned with a lumenof the hub portion, whether or not axially aligned. The aligning of thelumens can occur during manufacture, such as when the hub portion andthe sheath are formed as a single integrated unit or when separatecomponents are joined together. In one embodiment, the tubular body isconfigured to expand while still providing the necessary stiffnessand/or kink resistance to the sheath.

An introducer sheath or portions thereof can be formed using one or morematerials. Typically, the materials used in forming the introducersheath are medical grade synthetic materials or plastics. Exemplarymaterials may include, but are not limited to, flexible PVC,polyurethane, silicone, liner low-density polyethylene (LLDPE),polyethylene, high density polyethylene, (DHPE), polyethylene-linedethylvinyl acetate (PE-EVA), polypropylene, latex, thermoplastic rubber,polytetrafluorethylene (PTFE), expandable polytetrafluorethylene(ePTFE), fluroethylene-propylene (FEP), perfluoralkoxy (PFA),ethylene-tetrafluoroethylene-copolymer (ETFE),ethylene-chlorotrifluoroethylene (ECTFE), polychloro-trifluoroethylene(PCTFE), polyimide (PI), polyetherimide (PEI), polyetherketone (PEEK),polyamide-imide (PAI), other fluoropolymers, and the like.

Exemplary materials used in the sheath or a portion of the sheath canalso include elastomers or thermoplastic elastomers. Examples ofelastomers include, but are not limited to, natural rubber, siliconerubber, polyurethane rubber, polybutadiene, polyisoprene,chlorosulfonated polyethylene, polysulfide rubber, epichlorohydrinrubber, resilin, ethylene propylene rubber, and the like or anycombination thereof. These materials provide the elasticity that enablethe sheath to expand and/or contract to accommodate theremoval/insertion of a medical device as required. Other materials thatcan be used can include, but are not limited to, dip coated typesilicones.

In other embodiments, the materials suitable for use in an introducersheath are configured to have chemical resistance, crack resistance, notoxicity, Food and Drug Administration (FDA) compliance,non-electrically conductive, dimensional stability, and/or be sterilizedby ethylene oxide, gamma radiation, autoclave, UV light, ozone, and thelike.

In addition, the selection of materials for a particular sheath candepend on a variety of factors that include, but are not limited to, aparticular stiffness and/or flexibility of the sheath or any portion ofthe sheath, including the desired column stiffness and strength toenable insertion of the sheath, a particular shear or split strength forthe sheath or any portion of the sheath, the ability to resist kinking,and the like. For example, the material used for the tubular body of theintroducer sheath may be selected based on shear strength or how easilyit can be split. Further, certain features of the sheath may be formedto enhance certain characteristics. For example, a strain relief portionmay be formed to resist kinking while the elongated tubular body may beformed to facilitate splitting.

When more than one material is used to form the sheath or to formspecific portions of the introducer sheath, the materials may beselected, in addition to the factors identified herein, on a bondstrength between the materials or on the elasticity of a particularmaterial. The bond strength, for example, may have an impact on thesplitability of the sheath or of a portion of the sheath. The bondstrength may also affect the ability of the sheath to expand withoutsplitting.

When an elastomer is used in the sheath or a portion of the sheath, theelasticity of the elastomer enables the sheath or a portion of thesheath to at least partially deform, resiliently deform, or elasticallyexpand as needed to accommodate a medical device and then return orsubstantially return to its configuration prior to deforming orexpanding. Advantageously, the ability to deform and/or expand permits adevice, such as an expanded or expandable balloon, to be withdrawnthrough the sheath without removing the sheath, for example from apatient's vasculature. This maintains access to the patient'svasculature without the difficulty of inserting another sheath ormedical device through the puncture site. Further, maintaining theintroducer sheath in place allows a physician or technician to insertone or more additional medical devices, such as a vessel closure device,using the introducer sheath.

Embodiments extending to methods, systems, and apparatuses for closingand/or sealing openings in a blood vessel or other body lumen formedduring a diagnostic or therapeutic procedure are described. Theseembodiments may be used in conjunction with embodiments of the devicethat is expandable to cooperate with medical devices. Some of theapparatuses of the present invention are configured to deliver a closureelement through tissue and into an opening formed in and/or adjacent toa wall of a blood vessel or other body lumen.

Since current apparatuses for sealing openings formed in blood vesselwalls may snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engagetissue adjacent to the opening can prove much more desirable and providea basis for a wide range of medical applications, such as diagnosticand/or therapeutic procedures involving blood vessels or other bodylumens of any size. Further, since current apparatuses for sealingopenings formed in blood vessel walls are typically one-size and do notprovide a mechanism to accommodate for variations in the size orconfiguration of the physician or clinicians hands, an apparatus thatvaries its operational configuration to accommodate for physician orclinician hand sizes can prove much more desirable and beneficial to themedical arts. These results, whether individually or collectively, canbe achieved, according to one embodiment of the present invention, byemploying an apparatus as shown in the figures and described in detailbelow.

The apparatuses of the present invention are configured to deliver aclosure element through tissue and into an opening formed in and/oradjacent to a wall of a blood vessel or other body lumen. The apparatuscan be configured to receive and retain a closure element such that theclosure element can be disposed substantially within the apparatus. Theapparatuses in accordance with the present invention generally include ahandle portion having a proximal end and a distal end, a locator andclip delivery assembly extending from the distal end of the handleportion, and a locator actuator disposed at the proximal end of thehandle portion.

FIGS. 1-15K generally illustrate several embodiments of medical devicesfor delivering a closure element that may be used in conjunction withembodiments of an expandable sheath. Other embodiments of medicaldevices may also be used conjunction with embodiments of an expandablesheath.

Referring now to FIG. 1, an exploded assembly view of one closureapparatus is shown in accordance with the present invention. As shown inFIG. 1, the apparatus can include a housing that receives or retains aplurality of tubular members. The tubular members can be concentricallydisposed within the housing of the device, with each tubular memberhaving an associated block member fixedly attached to the proximal endthereof. The block members can be configured to interact with each otheras well as with features of the housing, such as through movement of atriggering system. The interaction of the tubular members, the blocks,and the triggering system will be described in greater detail below.Also described below will be additional details regarding the handleportion of the housing and the manner by which the movement of thetubular members and the triggering system results in variation of thedevices operational configuration to accommodate for physician orclinician hand sizes.

With continued reference to FIGS. 1A and 1B, apparatus 100 can beprovided as one or more integrated components and/or discrete componentsthat may be retained within a housing 102, having a housing top half 380c and a housing bottom half 380 d (not shown). For example, apparatus100 can include a locator assembly 110 and a carrier assembly 120. Forpurposes of illustration, locator assembly 110 and carrier assembly 120are shown in FIG. 1A as including substantially separate assemblies. Asdesired, however, locator assembly 110 and carrier assembly 120 each canbe provided, in whole or in part, as one or more integrated assemblies.

Turning to FIGS. 1A-2, 4, and 6, the assembly 110 can include a locatorassembly 200. This locator assembly 200 can include flexible orsemi-rigid tubular body 210 (such as an elongate rail) with alongitudinal axis. Tubular body 210 can have a proximal end region 210 aand a distal end region 210 b and can include a predetermined length anda predetermined outer cross-section, both of which can be of anysuitable dimension. Distal end region 210 b of locator assembly 200, asshown in more detail in FIGS. 3B and 3C, can include a substantiallyrounded, soft, and/or flexible distal end or tip 220 to facilitateadvancement and/or retraction of distal end region 210 b into a bloodvessel or other opening in tissue. As desired, a pigtail (not shown) maybe provided on tip 220 to further aid atraumatic advancement of distalend region 210 b.

Distal end region 210 b of locator assembly 200 is selectablycontrollable between an unexpanded state, as shown in FIG. 3B, and anexpanded state, as shown in FIG. 3C. As shown in FIG. 3B, when anexpansion end 230 is in an unexpanded state, substantially flexiblemembers 232 are substantially axially aligned with locator assembly 200.Alternatively, when expansion end 230 is in an expanded state,substantially flexible members 232 are flexed outward.

Returning to FIG. 1B, a control member 250, such as a rod, wire, orother elongate member, may be moveably disposed within a lumen (notshown) formed by tubular body 210 and extending substantially betweenthe proximal end region 210 a and distal end region 210 b. Controlmember 250 may have proximal end region 250 a coupled with a controlblock 260, and a distal end region (not shown) of control member 250coupled with distal end region 210 b of locator assembly 200, expansionend 230, and/or the movable end regions of substantially flexiblemembers 232. Control block 260 may be formed of a metal or rigid plasticin a tubular shape, and may be adapted to be retained in control blockcavity 265 formed on the internal surface of housing bottom half 380 d,to thereby maintain control block 260 in a substantially fixed positionrelative to the housing 380. By moving tubular body 210 axially relativeto control member 250, the distal end region 210 b, expansion end 230,and/or the substantially flexible members 232 (FIG. 3B), are selectivelytransitioned between the unexpanded and expanded states.

With reference to FIG. 3A, a tubular body block 270 having proximalgroove 271 may be formed on proximal end 210 a of tubular body 210.Tubular body block 270 may be formed of metal, rigid plastic, or othersubstantially rigid material and may be formed integrally with orattached securely to tubular body 210. Proximal groove 271 and theproximal end of tubular body block 270 may have a shape adapted tocooperate with a pair of tabs 279 a, 279 b formed on a locator assemblyblock 280, whereby tubular body block 270 may be maintained in a fixedaxial relationship with the locator assembly block 280. In this way,tubular body block 270 and tubular body 210 (FIG. 1B) may advancedistally by distal advancement of locator assembly block 280.

A locator assembly spring 290 may be located coaxially with and maysubstantially surround a portion of tubular body block 270. Locatorassembly spring 290 may be located between and in contact with thedistal side of two of tabs 279 a, 279 b formed on locator assembly block280 and the proximal side of locator assembly spring stop 381 formed onthe inner surface of housing bottom half 380 d. The locator assemblyspring 290 so located may provide a force biasing to locator assemblyblock 280 in the proximal direction relative to housing 380.

Locator assembly block 280 may be formed of metal, plastic, or otherrigid material. A function of locator assembly block 280 may be to allowa user to apply a force causing distal movement of tubular body 210(FIG. 1) relative to control member 250 causing locator assembly 200(FIG. 2) to transition from the unexpanded state to the expanded state.Slot 281 may be formed in the proximal end of locator assembly block280. Slot 281 may have a size sufficient to accommodate control block260 and control block cavity 265, and to allow locator assembly block280 to travel axially relative to housing 380. As shown in FIG. 1, thedistal end of locator assembly block 280 may include a pair of distallyextending legs 282 a-b, with each of legs 282 a-b having a ramp 283 a-bon its inward facing surface. Finally, the locator assembly block 280may have a pair of distally extending release tabs 284 a-b, each ofrelease tabs 284 a-b having a detent 285 a-b.

As shown in FIGS. 2-3A, locator assembly block 280 may be slidablyreceived and retained within grooves formed in the proximal end ofhousing 380, with the proximal end of locator assembly block 280extending from the proximal end of housing 380. Control block 260 andcontrol block cavity 265 may be located in slot 281 formed in theproximal end of locator assembly block 280.

To release locator assembly 200, and enable it to slidably move withinthe grooves formed in the proximal end of the housing 380 and allowlocator assembly 200 to transition from its expanded state to itsunexpanded state, the apparatus 100 can include a locator release system490 (FIG. 1A). Turning to FIG. 1A, locator release system 490 of theapparatus 100 may include locator release rod 491 having release tabspacer block 492 formed on its proximal end. Locator release rod 491 andrelease tab spacer block 492 may be received and retained in a grooveformed on the interior surface of housing bottom half 380 d. Release tabspacer block 492 may be integrally formed with or attached to theproximal end of locator release rod 491 and may be formed of metal,plastic, or other rigid material. Release tab spacer block 492 may havea shape and size adapted to fit between release tabs 284 a-b formed onlocator assembly block 280, thereby biasing release tabs 284 a-b outwardand causing outward facing detents 285 a-b to engage retaining grooves286 a-b (FIG. 1B) formed on the interior of housing 380. As long asdetents 285 a-b are thus engaged with retaining grooves 286 a-b inhousing 380, locator assembly block 280 is held in an axial positionagainst the spring force imparted in the proximal direction by locatorassembly spring 290.

With continued reference to FIG. 1A, the distal end of locator releaserod 491 may have an engagement member 493 that has an inward bend on thedistal end of locator release rod 491. As described more fully below,engagement member 493 on locator release rod 491 may be positionedwithin the apparatus 100 such that when closure element 500 isdelivered, engagement member 493 is engaged and caused to move axiallyin the distal direction, thereby disengaging release tab spacer block492 from locator assembly block 280 and causing locator assembly 200simultaneously to transition from an expanded state to an unexpandedstate.

Returning to FIG. 1A, the carrier assembly 120 may be coupled with, andslidable relative to, locator assembly 200. Carrier assembly 120 may beconfigured to receive and retain closure element 500, which may bedisposed substantially within carrier assembly 120. Carrier assembly 120may be further configured to position closure element 500 substantiallyadjacent to an opening to be closed, and to deploy closure element 500.Upon being deployed, closure element 500 can maintain a reducedcross-section but may also temporarily and substantially uniformlyexpand beyond the natural cross-section of closure element 500. Ineither case, closure element 500, when deployed, can engage an amount ofthe blood vessel wall and/or tissue adjacent to the opening. Thereafter,closure element 500 may be configured to return to the naturalcross-section, optionally substantially uniformly, such that the bloodvessel wall and/or tissue are drawn substantially closed and/or sealed.

As shown in FIG. 1A, carrier assembly 120 may include a tube set 305 ofat least one tubular member. For instance, the illustrated tube set caninclude carrier member 310, pusher member 320, cover member 330, andsupport member 340, also shown in FIG. 8. Carrier member 310, pushermember 320, cover member 330, and support member 340 may be provided asa plurality of nested, telescoping members with a common longitudinalaxis. Carrier member 310 may be configured to receive and supportclosure element 500. While being disposed on carrier member 310, closureelement 500 may be deformed from the natural, planar configuration toform a substantially tubular closure element 500″, as shown in FIGS.14A-14G, and as described herein.

Returning to FIG. 1A, carrier member 310 may include a proximal endregion (not shown) and distal end region (not shown). Carrier member 310may also define lumen 314, which may extend substantially between theproximal end region and distal end region of the carrier member 310 andconfigured to slidably receive at least a portion of tubular body 210 oflocator assembly 200 and/or support member 340. Although the exteriorcross-section of the carrier member 310 may be substantially uniform,the distal end region of carrier member 310 may have a cross-sectionthat increases distally, as illustrated in FIG. 1A, for substantiallyuniformly expanding substantially tubular closure element 500 (FIG. 14G)beyond natural cross-section 530 (FIG. 14A) of closure element 500″ whensubstantially tubular closure element 500″ is deployed. Alternatively,distal end region of carrier member 310 may be formed with a uniformcross-section to deploy closure element 500 without cross-sectionalexpansion.

Pusher member 320 may have proximal end region (not shown) and distalend region (not shown). Pusher member 320 may be coupled with, andslidable relative to, carrier member 310. Pusher member 320 may includea predetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension and can be configured to slidablyreceive carrier member 310 such that distal end region of pusher member320 may be offset proximally from distal end region of carrier member310. As desired, the predetermined length of pusher member 320 may besubstantially equal to a predetermined length of carrier member 310. Apredetermined length of pusher member 320 may be less than apredetermined length of carrier member 310 such that carrier member 310and pusher member 320 may at least partially define a space 360 (FIG. 8)distal to distal end region of pusher member 320 and along the peripheryof carrier member 310.

Pusher member 320 may be substantially tubular and can define a lumen324 that may extend substantially between proximal end region of pushermember 320 and distal end region of pusher member 320 and configured toslidably receive at least a portion of the carrier member 310. Thecross-section of pusher member 320 may be substantially uniform anddistal end region of pusher member 320 can include one or morelongitudinal extensions 325, which may extend distally from pushermember 320 and along the periphery of carrier member 310. Longitudinalextensions 325 may be biased such that longitudinal extensions 325extend generally in parallel with the common longitudinal axis ofcarrier assembly 120. Longitudinal extensions 325 may be sufficientlyflexible to expand radially, and yet sufficiently rigid to inhibitbuckling as distal end region of pusher member 320 is directed distallyalong carrier member 310 and engages the distally-increasingcross-section of distal end region of carrier member 310 to deployclosure element 500.

Cover member 330 may be configured to retain closure element 500, in itsgenerally tubular configuration, substantially within the carrierassembly 120 prior to deployment. Being coupled with, and slidablerelative to, pusher member 320, cover member 330 has proximal end region(not shown) and distal end region (not shown), a predetermined lengthand a predetermined cross-section, both of which can be of any suitabledimension. Cover member 330 may be formed as a substantially rigid,semi-rigid, or flexible tubular member with an inner periphery and anouter periphery, and may define a lumen 334. Lumen 334 may extendssubstantially between proximal and distal end regions of cover member330 and may be configured to slidably receive at least a portion ofpusher member 320. When cover member 330 is properly positioned withincarrier assembly 120, as schematically illustrated in FIG. 15A, distalend region may be configured to extend over the space 360, therebydefining annular cavity 370 for receiving and retaining substantiallytubular closure element 500″.

The cross-section of cover member 330 may be substantially uniform, anddistal end region of cover member 330 may include one or morelongitudinal extensions 335, which extend distally from cover member 330and along an outer periphery of pusher member 320, as shown in FIG. 8.Although longitudinal extensions 335 can extend generally in parallelwith the longitudinal axis of the tube set 305, longitudinal extensions335 may be biased such that the plurality of longitudinal extensions 335extend substantially radially inward. Thereby, longitudinal extensions335 may at least partially close lumen 334 substantially adjacent todistal end region of cover member 330.

With reference to FIGS. 1B and 15A, to permit closure element 500 to bedeployed from annular cavity 370, longitudinal extensions 335 may besufficiently flexible to expand radially to permit distal end region 310b of carrier member 310 to move distally past cover member 330 to openannular cavity 370 such that distal end region of cover member 330 nolonger extends over the space 360.

When carrier assembly 120 is assembled as a plurality of nested,telescoping members, as shown in FIGS. 2 and 8, carrier member 310 is atleast partially disposed within, and slidable relative to, a lumen ofpusher member 320, and support member 340 is slidably relative to pushermember 310. Pusher member 320, in turn, is at least partially disposedwithin, and slidable relative to, lumen 334 of cover member 330. Tocouple carrier assembly 120 with locator assembly 200, tubular body 210of locator assembly 200 may be at least partially disposed within, andslidable relative to, lumen 314. The longitudinal axis of locatorassembly 200 may be substantially in axial alignment with the commonlongitudinal axis of carrier member 310, pusher member 320, and covermember 330.

The apparatus 100 may also include support member 340 as shown in FIG.1A. Support member 340 may be configured to slidably receive tubularbody 210 of locator assembly 200 and provide radial support for distalend region 210 b of tubular body 210 when locator assembly 200 iscoupled with the carrier assembly 120. Carrier assembly 120 canadvantageously include support member 340, for example, if tubular body210 is not sufficiently rigid or under other circumstances in whichsupport for tubular body 210 might be desirable. It also will beappreciated that support member 340 may also be configured to inhibitlongitudinal extensions 335, which extend from distal end region ofcover member 330, from expanding prematurely when closure element 500 isdeployed. If longitudinal extensions 335 were to expand prematurely,they may become hung up on an introducer sheath or other delivery member(if an introducer sheath or delivery member is used), the tissue, or thewall of the blood vessel. This may interfere with the proper advancementor other movement of cover member 330 and carrier assembly 120.

Support member 340 may be formed as a substantially rigid, semi-rigid,or flexible tubular member, and may include proximal end region 340 aand distal end region 340 b. Having an outer periphery, support member340 may define lumen 344, extending substantially between proximal endregion 340 a and distal end region 340 b and configured to slidablyreceive and support at least a portion of tubular body 210 of locatorassembly 200. Support member 340, in turn, can be at least partiallyslidably disposed within lumen 314 of carrier member 310 such thattubular body 210 of locator assembly 200 is coupled with, and slidablerelative to, carrier member 310 in the manner described in more detailabove.

Support member 340 may have a predetermined length and a predeterminedcross-section, both of which can be of any suitable dimension, and mayhave a substantially uniform cross-section. Although shown and describedas being substantially separate for purposes of illustration, it will beappreciated that carrier member 310, pusher member 320, cover member330, and/or support member 340 may be provided, in whole or in part, asone or more integrated assemblies.

With reference to FIG. 8, support member 340 may also include a distalend that is blunt, rounded and/or includes a radius or curved portionthat may prevent and/or eliminate damage to tubular body 200 as tubularbody is moved with respect to support member 340. In some cases duringdeployment, as discussed in more detail below, tubular body 200 may beinserted into a lumen of an introducer at such an angle as to requiretubular body 200 to flex with respect to tube set 305 as much as betweenabout 0 degrees and 90 degrees, preferably between about 10 degrees and90 degrees and more preferably between 30 degrees and 60 degrees, forexample when used in conjunction with a femoral artery. Theabove-described distal end of the distal end region 340 b preventsand/or eliminates damage to tubular body 200 that may result from asharp edge pressed along tubular body 200 during advancement of tube set305, and more particularly, support member 340 and the distal end of thedistal end region 340 b.

Illustratively, the radii of the distal end of the support member 340can have various sizes and configurations. In one configuration, thedistal end radii can be about 0.002 inches. In still anotherconfiguration, the distal end radii can be about 0.004 inches. In stillanother configuration, the distal end radii can be about 0.002 inches orgreater. Increasing the radii of the distal end of support member 340 toabout 0.004 inches, for instance, can decrease the amount of forcerequired to overcome a bend in locator assembly 200 over those deviceshaving a distal end radii of about 0.002 inches. This is because thelarger radius on the distal end of the support member 340 may decreasethe chance of the support member cutting into the tubular body 210 ofthe locator assembly 200.

In addition to the above, with the distal end having a radii greaterthan 0.002 inches, such as but not limited to 0.004 inches, there is adecrease in the possibility that the support member 340 may cut orotherwise damage the locator assembly 200 during positioning of thedistal end of the apparatus 100 and subsequent deployment of the closureelement 500. Further, a radii greater than 0.002 inches, such as but notlimited to 0.004 inches, may not increase the forces used to split anintroducer sheath and may not elongate the introducer sheath duringpositioning and deploying of the closure element 500.

With reference to FIGS. 1A and 1B, carrier assembly 120 may also includea portion of housing 380. For instance, the carrier assembly 120 canoptionally include the top half 380 c of housing 380, illustrated inFIG. 1A, and the bottom half 380 d is shown in FIG. 1B. It will beunderstood, however, that housing 380 may be separate from the carrierassembly 120, while retaining and/or receiving all or a portion of thecarrier assembly 120.

Housing 380 may be formed as an elongate member with a longitudinalaxis, a periphery and may include proximal end region 380 a and distalend region 380 b. Thereby, when apparatus 100 is assembled, tubular body210 of locator assembly 200 may be at least partially disposed within,and slidable relative to, tube set 305 such that distal end region 210 bof tubular body 210 extends beyond distal end regions of the tube set305. Tubular body 210, carrier member 310, pusher member 320, covermember 330, and, if provided, support member 340 may be at leastpartially disposed within, and slidable relative to, housing 380. Theproximal end region 210 a of tubular body 210 and the proximal endregions of tube set 305 can be at least partially disposed within, andslidable relative to, housing 380. The distal end regions of the tubularbody 210 and the tube set 305 may extend from distal end region 380 b ofhousing 380 such that common longitudinal axis (not shown) of tube set305 may be substantially axially aligned with longitudinal axis (notshown) of housing 380. When configured to slidably retain respectiveproximal end regions of the tubular body 210 and the tube set 305,housing 380 supports tube set 305 and can have one or more handles 391,392 to facilitate use of apparatus 100. Handles 391, 392 may extend,optionally substantially radially, from the outer periphery of housing380 and can be provided as illustrated or in any manner known in theart.

To facilitate deployment of the closure element 500, the apparatus 100can include a triggering system 400, shown in FIG. 2, which cooperateswith a portion the locator assembly 200. For instance, a portion oflocator assembly 200 and a portion of triggering system 400 maycooperate and be accessible externally to housing 380, as shown in FIGS.1A and 1B. As shown in FIGS. 1A, 1B, 4-7, triggering system 400 ofapparatus 100 may be disposed substantially within housing 380.Triggering system 400 may be configured to control the relative axialmovement and/or positioning of distal end regions of the tube set 305and/or locator assembly distal end region 210 b. Axial motion of one ormore of carrier member 310, pusher member 320, cover member 330, andsupport member 340 and/or tubular body 210 may be attained, for example,by applying an axial force to triggering extension 405.

Triggering system 400 may include a set of block members includingcarrier block 410, pusher block 420, cover block 430, and support block440, each of which may be formed integrally with or securely attached toits respective member of carrier assembly 120. The block members may beadapted to selectably couple and decouple carrier member 310, pushermember 320, cover member 330, and support member 340 relative to oneanother in order to provide axial movement of those components in apredetermined manner intended to deliver closure element 500 in themanner described herein. For example, when carrier assembly 120 reachesa first predetermined distal position, support member 340 may bedecoupled from carrier member 310, pusher member 320, and cover member330, and may be thereafter substantially inhibited from further axialmovement. Thereby, carrier member 310, pusher member 320, and covermember 330 may be directed distally as support member 340 remainssubstantially stationary. Subsequently, carrier member 310 and covermember 330 can be decoupled from pusher member 320 and thereby inhibitedfrom further axial movement. Pusher member 320 may be directed distallyas support member 340, carrier member 310, and cover member 330 remainsubstantially stationary, as described more fully herein.

Carrier block 410 may be disposed on proximal end region of carriermember 310 and may include trigger extension 405, which extends througha slot in housing 380 to the exterior of housing 380, accessible by auser. This carrier block 410, as shown in FIG. 3A, may include a pair ofgrooves 413 a-b, which may be formed on a peripheral surface of carrierblock 410. These grooves 413 a-b may be adapted to receive and retain apair of tabs 445 a-b formed on a pair of legs 444 a-b extending distallyfrom support block 440, thereby selectably coupling support block 440 tocarrier block 410. Carrier block 410, as illustrated in FIG. 1A, mayalso include a pair of distal tabs 416 a-b extending from the distal endof carrier block 410, and adapted to engage a pair of slots 423 a-bformed on the proximal end of pusher block 420.

As shown in FIGS. 1A and 3A, carrier block 410 may also include a pairof arms 414 a-b extending in the proximal direction from the proximalend of carrier block 410, each of arm 414 a-b having an outward directedtab 415 a-b at its proximal end. The tabs 415 a-b may be adapted toselectably engage a pair of slots 387 a-b (FIG. 1B) formed on theinterior surface of housing 380 near its proximal end and, when soengaged, to fix the axial position of carrier block 410 and, with it,carrier assembly 120 relative to housing 380. The tabs 415 a-b may bedisengaged from slots 387 a-b FIG. 1B) in housing 380 when locatorassembly block 280 is moved axially in the distal direction in thefollowing manner. As locator assembly block 280 is advanced distally,the interior surfaces of the ramps 283 a-b on locator assembly blocklegs 282 a-b engage the exterior surfaces of tabs 415 a-b and causecarrier block arms 414 a-b to flex inward, releasing tabs 415 a-b fromthe slots 387 a-b in the housing, thereby freeing carrier block 410 andcarrier assembly 120 to move axially. Thus, axial movement of carrierblock 410 within apparatus 100 may be inhibited until locator assemblyblock 280 is advanced to transition locator assembly 200 to the expandedcondition, simultaneously releasing tabs 415 a-b on carrier block 410.

Pusher block 420 may be disposed on proximal end region of pusher member320. As described above, pusher block 420 may include a pair of slots423 a-b formed on its proximal end, and adapted to selectably engagedistal tabs 416 a-b extending from the distal end of carrier block 410.Pusher block 420 may also include a pair of grooves 424 a-b formed onits peripheral surface, the grooves 424 a-b being adapted to engage apair of tabs 435 a-b formed on a pair of forks 434 a-b extending fromthe proximal side of cover block 430 to selectably couple cover block430 to pusher block 420.

Cover block 430 may be disposed on proximal end region of cover member330. As described above, cover block 430 may include a pair of forks 434a-b extending from the proximal end of the cover block 430, each offorks 434 a-b having an inward directed tab 435 a-b adapted to engagegrooves 424 a-b on the peripheral surface of pusher block 420 toselectably couple cover block 430 to pusher block 420.

Support block 440 may be disposed on proximal end region 340 a ofsupport member 340. As described above, support block 440 may include apair of legs 444 a-b extending from the distal end of the support block440, each of legs 444 a-b having an inward directed tab 445 a-b adaptedto engage grooves 413 a-b formed on the surface of carrier block 410 toselectably couple support block 440 to carrier block 410.

Carrier block 410, pusher block 420, cover block 430, and support block440 are shown in FIGS. 2, 3A, 4-5 in their fully coupled state, withsupport block 440 coupled to carrier block 410, pusher block 420 coupledto carrier block 410, and cover block 430 coupled to pusher block 420.In this arrangement, carrier assembly 120 may include a coaxial set oftubes as shown in FIG. 8, with support member 340 slidably retainedsubstantially within carrier member 310, which is in turn slidablyretained substantially within pusher member 320, which is in turnslidably retained substantially within cover member 330.

Triggering system 400 of apparatus 100 may include an energy storingelement that is used in the final stage of closure element 500 deliveryprocesses. The energy storing element, such as, but not limited to, aspring, such as pusher spring 425 shown in FIGS. 1A, 1B, 6 and 7, may besubstantially retained in a spring cavity 417 formed in carrier block410 and coaxially surrounds a proximal end region of carrier member 310.Pusher spring 425 is capable of expanding and contracting, storingpotential energy as it is contracted and releasing energy as it expands.In its fully expanded state, the pusher spring 425 has a length that isgreater than the length of spring cavity 417. The cross-sectionaldimension of pusher spring 425 may be such that it backs up against andcontacts the proximal end of pusher block 420. Thus, when pusher spring425 is in place between carrier block 410 and pusher block 420, pusherspring 425 is capable of imparting a force biasing carrier block 410away from pusher block 420.

Prior to delivery of closure element 500, the distal end of carrierblock 410 may be in physical contact with the proximal end of pusherblock 420. In this pre-delivery condition, pusher spring 425 is in acontracted state and may be maintained within spring cavity 417. A catchmember 418 serves the function of maintaining the carrier block 410 andpusher block 420 in the pre-delivery condition against the spring forceof pusher spring 425, the force of which would otherwise force apartcarrier block 410 from pusher block 420. Catch member 418 may be aU-shaped piece of metal, plastic, or other rigid material that engagesfirst groove 419 a formed on the surface of carrier block 410 and secondgroove 419 b formed on the surface of pusher block 420. With referenceto FIGS. 1A and 1B, pusher block 420 includes hole 426 extending througha portion thereof, with one end of hole 426 opening into groove 419 b.Hole 426 is adapted to receive trip pin 427. During the closure elementdeployment process, trip pin 427 is advanced through hole 426, where itencounters catch member 418 retained in the groove 419 b. Furtheradvancement of trip pin 427 causes catch member 418 to become disengagedfrom groove 419 b, thereby releasing the force of pusher spring 425.

The operation of the triggering system 400 of the apparatus 100 isillustrated in FIGS. 2-8 with the closure element 500 disposedsubstantially within the apparatus 100. As shown in FIGS. 2-3B,apparatus 100 has an initial position in which locator assembly block280 is extended proximally and triggering system 400 is in its mostproximal position. Accordingly, the locator assembly 200 is in itsunexpanded state, as shown in FIG. 3B. At a point in time that thedistal end region 210 b of the locator assembly 200 has been positionedas desired (for example, within the blood vessel), locator assemblyblock 280 may be depressed distally, as shown in FIG. 4, therebytransitioning locator assembly 200 to the expanded state, as shown inFIG. 3C, and, simultaneously, releasing triggering system 400 from theinitial position (in the manner described above) such that triggeringsystem 400 can be advanced distally within the housing 380.

Triggering system 400 can then be advanced distally within housing 380,thereby advancing tube set 305 into position adjacent the blood vessel.At a first predetermined position, shown in FIGS. 4 and 5, support block440 may encounter a support stop (not shown) on the interior surface ofhousing bottom half 380 d that inhibits support block 440 from advancingfurther distally. As a result, an application of additional distal forceto triggering system 400 may cause support block 440 to decouple fromcarrier block 410. More specifically, the tabs 445 a-b on the legs 444a-b of support block 440 may disengage from grooves 413 a-b on carrierblock 410. Thus, support block 440 may remain in the position shown inFIGS. 4 and 5, while carrier block 410 may advance further distally uponapplication of force to triggering system 400.

Turning to FIGS. 6-8, as the triggering system 400 is advanced furtherdistally; cover block 430 may engage a cover stop on the interiorsurface near the distal end region 380 b of housing 380, therebyinhibiting additional distal advancement of cover block 430. Inaddition, trigger extension 405 may engage handle 391 of the apparatus100, thereby inhibiting additional distal advancement of carrier block410.

Closure element 500 next may be deployed by releasing pusher spring 425,which may cause pusher block 420 (and, thus, pusher member 320 (FIG.1A)) to advance distally, deploying closure element 500 in the mannerdescribed above. As previously described, pusher spring 425 may bereleased by disengaging catch member 418 from groove 419 b on pusherblock 420, thereby releasing pusher spring 425 to force the pusher block420 and, thus, pusher member 320 distally relative to the carrier block410. This action may cause pusher member 320 to deploy closure element500 from within tube set 305. The catch member 418 may be disengagedfrom groove 419 b by applying a force to a trigger 401, which, in thedeployment position, may be aligned with trip pin 427 retained in pusherblock 420. A trigger spring 402 may bias trigger 401 outward relative tohousing 380, with a portion of the trigger 401 extending through a hole130 (FIG. 1B) in housing 380. A user may apply an inward directed forceto trigger 401 to counteract the biasing force of trigger spring 402 andforce trigger 401 against the trip pin 427.

With reference to FIGS. 1A and 6, in addition to deploying closureelement 500, the distal advancement of pusher block 420 may also causelocator release system 490 to activate, thereby transitioning locatorassembly 200 from the expanded state to the unexpanded state. As pusherblock 420 advances distally to deploy closure element 500 in the mannerdescribed above, pusher block 420 may also engage engagement member 493of locator release system 490 and may advance locator release rod 491distally. This action may cause release tab spacer block 492 todisengage from release tabs 284 a-b on locator assembly block 280 (seeFIG. 1), thereby releasing locator assembly block 280, which may returnto its proximal position, causing locator assembly 200 to return to theunexpanded state. An indicator window (not shown) may be formed inhousing 380 to give a visual indication that tab spacer block 492 hasdisengaged and that locator assembly 200 has returned to the unexpandedstate. In the present embodiment, the deployment of closure element 500and locator release actions may occur nearly simultaneously.

Referring now to FIGS. 9-13, an alternative embodiment of the apparatusis shown in accordance with the present invention. The apparatus of thealternative embodiment may be functionally similar to that of the devicepreviously described above and shown in FIGS. 1-8 in most respects,wherein certain features will not be described in relation to thealternative embodiment wherein those components may function in themanner as described above and are hereby incorporated into thealternative embodiment described below.

Generally, the apparatus 1000 illustrated in FIGS. 9-13 can accommodatefor variations in the size of the physicians hand and grip byselectively reducing the distance between the device's handle portionand a portion of the triggering system usable to deploy the closureelement and/or move a carrier assembly. Advancement of a locatorassembly for locating the blood vessel wall prior to deploying theclosure element may at least partially advance a portion of thetriggering system of the apparatus including a trigger extensiongraspable by a physician or clinician. This partial movement may reducethe gap or throw between the trigger extension and the handle portion.In this manner, a physician or clinician may not need to stretchuncomfortably to position a thumb or finger on the trigger extension,grasping the handle portion, and maintaining the device in the desiredorientation relative to the tissue and/or the puncture site.Furthermore, reducing the gap or throw between the trigger extension andthe handle portion may enable the physician or clinician to moreeffectively apply a deploying force.

As shown in FIG. 9, the apparatus 1000 can include a housing 1380 thatmay include housing halves 1380 c and 1380 d (FIG. 10). These housinghalves 1380 c and 1380 d (FIG. 10), either individually or collectively,can form one or more handle, hand grip, or finger portions which aphysician or clinician can grip or hold to manipulate the apparatus1000. As illustrated, the apparatus 1000 may include finger grip 1391and/or finger grip 1392 at a distal end and finger grips 1394 a and/or1394 b on the proximal end of housing 1380 to facilitate use of locatorassembly 1110, and specifically plunger 1280.

In addition, the apparatus 1000 may include handle, hand grip, and/orfinger portion disposed on the distal end of housing 1380 configured tobe engaged by a user when advancing housing 1380 to deploy closureelement 500 (FIG. 1A). This handle, handle portion, and/or hand gripportion may include a shaped grasping portion 1600 and an elongategrasping portion 1392 spaced apart from the shaped grasping portion1600. Each of the portions 1392 and 1600 may be contoured to be receivedby a user's hand. For instance, the grasping portion 1600 may provide astable base upon which the physician or clinician can move the device orapparatus as the closure element 500 is positioned and deployed. Thisgrasping portion 1600 may have a shaped portion 1602 with a curvedconfiguration that can receive at least a thumb or finger of thephysician or clinician as the physician or clinician holds the apparatus1000. The curved configuration or profile may allow the physician tograsp the handle or handle grip portion while resting their hand, wrist,or forearm upon a patient during the procedure, such as deployment ofthe closure element 500, thereby providing stability during use of theapparatus 1000.

It will be understood that although reference is made to one particularconfiguration of the handle, hand grip, and/or finger portions, variousother handle portion configurations may perform the function ofproviding a stable base for manipulation of the apparatus 1000. Forinstance, and not by way of limitation, the handle portion may be planarrather than curved. Further, the handle portion may include one or morefinger receiving holes. In addition, the handle portion may include amaterial to provide cushioning or comfort to the physician and/orclinician. For example, flexible, yielding, and/or elastic materials maybe formed or applied to all or a portion of the handle portion.

Referring now to FIGS. 9 and 10, apparatus 1000 may be provided as oneor more integrated components and/or discrete components. For instance,and not by way of limitation, apparatus 1000 may include locatorassembly 1110 and/or carrier assembly 1120. For purposes ofillustration, locator assembly 1110 and carrier assembly 1120 are shownin FIG. 10 as having substantially separate assemblies. As desired,however, locator assembly 1110 and carrier assembly 1120 may each beprovided, in whole or in part, as one or more integrated assemblies.Portions of locator assembly 110 and/or carrier assembly 120 may also beused as part of apparatus 1000. Alternatively, modified versions oflocator assembly 110 and/or carrier assembly 120 may be used.

Locator assembly 1110 may be constructed in the manner previouslydescribed above, including a flexible or semi-rigid tubular body (suchas an elongate rail) with a longitudinal axis. The tubular body may havea proximal end region and a distal end region and/or may include apredetermined length and a predetermined outer cross-section, both ofwhich may be of any suitable dimension. The distal end region of thelocator assembly may include a substantially rounded, soft, and/orflexible distal end or tip to facilitate atraumatic advancement and/orretraction of the distal end region into a blood vessel or other openingin tissue. As desired, a pigtail (not shown) may be provided on thedistal end to further aid atraumatic advancement of the distal endregion. The distal end region of locator assembly 1110 may be selectablycontrollable between an unexpanded state and an expanded state.

As shown in FIG. 10, apparatus 1000 may include carrier assembly 1120which may be functionally equivalent to carrier assembly 120 (FIG. 1A)described above and will not be described in detail with regard to thepresent embodiment. As with carrier assembly 120, carrier assembly 1120may be coupled with and/or be slidable relative to locator assembly1110. Carrier assembly 1120 may be configured to receive and retain theclosure element 500 (shown in FIGS. 14A-14G), which may be disposedsubstantially within carrier assembly 1120. Carrier assembly 1120 mayfunction to position closure element 500 substantially adjacent to anopening to be closed, and to deploy closure element 500.

Referring now to FIGS. 10 and 11, locator assembly 1110 of the presentembodiment will be described in greater detail. As with the previouslocator assembly 110, a control member 1250, such as a rod, wire, orother elongate member, may be moveably disposed within a lumen (notshown) formed by tubular body 1210 and may extend substantially betweenthe proximal end region and the distal end region of the lumen. Controlmember 1250 may have a proximal end region 1250 a that may be coupledwith a control block 1260, and a distal end region that may be coupledwith the distal end region of locator assembly 1110, expansion members1230, and/or movable end regions of substantially flexible members, suchas flexible members 232 (FIG. 3B). Control block 1260 may be constructedin a tubular shape and formed of a metal or rigid plastic, and may beadapted to be retained in control block cavity 1265 (FIG. 11A) formed onthe internal surface of the housing bottom half 1380 d, to therebymaintain control block 1260 in a substantially fixed position relativeto housing half 1380 d and so housing 1380. The locator assembly 1110may selectively transition distal end region 1210 b, expansion members1230, and/or the substantially flexible members between the unexpandedand expanded states by moving tubular body 1210 axially relative tocontrol member 1250. Additionally as shown in FIG. 11A, apertures 1383may be placed adjacent to and/or in communication with detents 1385,wherein in use as described below, tabs 415 a and 415 b (FIG. 1A) mayengage the detents 1385 during use. Apertures 1383 may be configured toreceive the tip of a medical device, such as a tip of a dilator from asheath assembly, wherein the tip of the dilator may be used to disengagethe tabs 415 a and 415 b (FIG. 1A) from the detents 1385 therebyreleasing the locked position of the device. This may enable a user tomove the trigger assembly 1400 (FIG. 10) proximally (toward the user)after the clip has been deployed in the event that the device becomesstuck within the patient, thereby providing a safety release mechanism.It shall be appreciated that the apertures 1383 may be replaced by otherfeatures such a recessed buttons that become exposed with the engagementof the tabs with the detents and/or a specific tool may be provided withthe device.

With reference to FIGS. 10 and 11B, to facilitate movement of carrierassembly 1120 to reduce the distance between a trigger extension 1405and the distal end of housing 1380, the functionality of locatorassembly block 280 (FIG. 1A) may be provided through the combination ofa plunger 1280, a tubular body block 1270, and a spring retainer 1290.In addition to providing the functionality of locator assembly block280, including controlling movement of expansion members 1230, plunger1280, tubular body block 1270, and spring retainer 1290 and/or aidingwith moving trigger extension 1405 toward the distal end of housing1380.

With reference to FIG. 11B, plunger 1280 may include two spaced apartlegs 1282 a-b, which may be separated by a plunger member 1284 to form aslot 1281 therebetween. The legs 1282 a-b may be spaced apartsufficiently to accommodate and/or receive a portion of tubular bodyblock 1270 and/or spring retainer 1290 therebetween. Each of the legs1282 a-b may have a stepped configuration, such as the configurationshown in FIG. 11D. Plunger 1280 may be slidably received and/or retainedwithin grooves formed in the proximal end of housing 1380, with theproximal end of plunger 1280 extending from the proximal end of housing1380.

Plunger 1280 may be constructed of metal, plastic, and/or other rigidmaterials. The proximal end of plunger 1280 may have a slot 1281 formedtherein. Slot 1281 may have a size sufficient to accommodate controlblock 1260 and control block cavity 1265 and to allow plunger 1280 totravel axially relative to housing 1380. As mentioned, the distal end ofplunger 1280 may include a pair of distally extending legs 1282 a-b withoptional ramps 1283 a-b on respective inward facing surfaces. Inaddition, a recess 1285 may be formed in each leg 1282 a-b within whicha protrusion 1286 may move. The protrusion 1286 may have a detent 1288that can interlock with the tubular body block 1270 and/or springretainer 1290 as plunger 1280 is moved distally.

With reference to FIGS. 11B and 11E, tubular body block 1270 may beformed integrally with or attached securely to tubular body 1210. Thetubular body block 1270 may include a pair of extending legs 1272 a-b.Each of legs 1272 a-b may have a ramp portion 1273 a-b on its inwardfacing surface. Ramp portions 1273 a-b may cooperatively engage tabs,not shown but similar to tabs 415 a-b (FIG. 1A), of carrier block 1410(FIG. 12). In an initial state, the tabs 415 a-b (FIG. 1A) may beengaged in slots 1387 a-1387 b (FIG. 11A) formed in housing half 1380 dto hold triggering system 1400 (FIG. 10) in a fixed axial relationshipwith housing 1380.

An intermediate member 1274 may extend between legs 1272 a-b. Theintermediate member 1274 may include a pair of upwardly extendingextensions 1276 a-b and/or a tab 1278, shown in dotted lines in FIG.11B. Extensions 1276 a-b may be received within the space between legs1282 a-b of plunger 1280. Stated another way, tubular body block 1270may be held in a fixed axial relationship with respect to plunger 1280through the engagement of legs 1282 a-b and legs 1272 a-b. The tab 1278may be adapted to cooperate with spring retainer 1290 and/or lock with aportion of spring retainer 1290 as plunger 1280 moves distally, as willbe described in more detail hereinafter.

A tubular portion 1279 may extend from intermediate member 1274 in thesame direction as legs 1272 a-b. The tubular portion 1279 may slidablycooperate with spring retainer 1290 and may receive tubular body 1210within a lumen. Further, tubular portion 1279 may cooperate with alocator assembly spring 1289 (FIG. 10) which may bias tubular body block1270 and/or spring retainer 1290 relative to housing 1380.

As shown in FIGS. 11B and 11F, spring retainer 1290 may include a wallportion 1291 with a recess 1292 that may receive tubular portion 1279 oftubular body block 1270. The wall portion 1291 may define a channel 1294within which the locator assembly spring 1289 (FIG. 10) may be received.For instance, locator assembly spring 1289 (FIG. 10) may extend fromwall portion 1291 to locator assembly spring stop 1381 (FIG. 11A) tobias movement of spring retainer 1290, tubular body block 1270, and/orlocator assembly 1110.

Spring retainer 1290 may further include arms 1296 a-b. Arms 1296 a-bmay include a movable portion 1297 a-b that may flex or move to receivetab 1278 of tubular body block 1270. For instance, tab 1278 may includecurved surfaces that may cooperate and/or receive a portion of movableportion 1297 a-b as tubular body block 1270 moves relative to springretainer 1290. Alternatively, tab 1278 may be positioned within a space1299 between wall portion 1291 and movable portion 1297 a-b beforemanipulation or operation of apparatus 1000. It will be understood thatother portions of arms 1296 a-b can flex or move, whether or not movableportions 1297 a-b move.

In addition to arms 1296 a-b, spring retainer 1290 may include releasetabs 1298 a-b. These release tabs 1298 a-b may function in a similarmanner to tabs 284 a-b (FIG. 1A). For instance, tabs 1298 a-b maycooperate with a locator release system 1490 in a manner substantiallysimilar to the embodiments described above. For example, release tabs1298 a-b may engage release cavity 1495 on housing 1380, and may be heldfrom releasing by release tab spacer block 1492.

Generally, plunger 1280, tubular body block 1270, and/or spring retainer1290 may be formed of metal, plastic, and/or other material, whether ornot rigid, substantially rigid, or flexible. As such, plunger 1280,tubular body block 1270, and/or spring retainer 1290 may be formed frommedical grade synthetic materials and/or materials that can besterilized or otherwise cleaned.

Turning now to FIGS. 12 and 13, illustrated are the operationalpositions of the apparatus 1000 in (i) an initial state with theexpansion members 1230 (FIG. 9) in an unexpanded condition and (ii) astate with the expansion members 1230 (FIG. 9) in an expanded condition.

With reference to FIG. 12, in the initial state, plunger 1280 may extendfrom the distal end of housing 1380, expansion members 1230 may be in anunexpanded condition, and locator assembly spring 1289, which can belocated coaxially with tubular body block 1270, may be located betweenspring retainer 1290 and the proximal side of locator assembly springstop 1381 formed on the inner surface of housing bottom half 1380 d. Inthis initial state, locator assembly spring 1289 may be held in a biasedstate. Optionally, a portion of carrier assembly 1120 (FIG. 10) may beassociated with legs 1282 a-b of plunger 1280 and contact carrier aportion of carrier assembly 1120 (FIG. 10).

Once a user presses on plunger 1280 to expand expansion members 1230,i.e. moving plunger 1280 toward expansion members 1230, tubular bodyblock 1270 and/or tubular body 1210 may advance distally by distaladvancement of plunger 1280. Upon advancement, and with reference toFIGS. 1A and 10-12, ramp members 1273 a-b may press tabs 415 a-b, whichare hidden by plunger 1280 in FIG. 12, releasing carrier block 1410 toslide axially in housing 1380. Advancing ramp members 1273 a-b mayrelease tabs 1298 a-b engaged in retaining grooves 1387 a-b incooperation with locator release system 1490. Locator release system1490 may be functionally equivalent to locator release system 490described above. Thus, advancing ramp members 1273 a-b may thereby fixspring retainer 1290 and tubular body block 1270 axially with respect tohousing 1380 and expansion members 1230 of locator assembly 1110 in anexpanded state. Also during advancement, tab 1278 of tubular body block1270 may advance between arms 1296 a-b of spring retainer 1290. Thisadvancement may extend the arms outwardly until tab 1278 advances pastthe ends of arms 1296 a-b, which may cause arms 1296 a-b to extendbehind tab 1278, thereby coupling spring retainer 1290 and tubular bodyblock 1270, and fixing tubular body block axially prior to activation oflocator release system 1490. Once advanced, the plunger 1280, in thepresent embodiment, may be locked into a distal position by legs 1272 aand 1272 b.

Further axial movement of plunger 1280 may allow the engagement ofdistal end 1283 b of leg 1282 b and carrier block 1410, thereby movingcarrier block 1410 distally along with carrier assembly 1120, asillustrated in FIG. 13. This additional movement of carrier assembly1120 may also move trigger extension 1405, generally shortening thedistance required to fully engage the carrier assembly 1120. Combiningthe deployment of locator assembly 1110 and the partial advancement ofcarrier assembly 1120 in a single step, may allow for a reduction intravel of the trigger block and trigger extension 1405. This reductionof travel may allow for a greater variation in user strength as well asthe physical size of a users hand to fit better with device 1000 asillustrated.

Once locator assembly 1110 is deployed, carrier assembly 1120 may beadvanced distally by exerting force on trigger extension 1405, and maybe fixed in the distal position in the manner described above withreference to other embodiments above. After the locator has beendeployed and the carrier assembly initially advanced, as shown in FIG.13, device 1000 may function in the manner described above with regardto other embodiments of the present invention and thus will not bedescribed in detail with regard to this embodiment.

In some embodiments, the tubular body block and the release block may beintegrally formed. When the tubular body block and the release block areintegrally formed, axial movement of the locator assembly block mayforce outward movement of tabs holding the tubular body block to thelocator assembly block, which may allow the integrally formed tubularbody block and release block to slide distally with respect to thelocator assembly block and may cause the release tabs to load thelocator release system to release as discussed above.

Referring now to FIGS. 14A-14G illustrating embodiments of a closureelement that can be used as part of or with the apparatus 100. Theclosure element, generally identified with reference numeral 500, mayhave a generally annular-shaped body defining a channel and one or morebarbs and/or tines for receiving and engaging the blood vessel or otherbody lumen wall and/or the tissue around the opening. Although theclosure element has a natural shape and size, the closure element can bedeformed into other shapes and sizes, as desired, and can be configuredto return to the natural shape and size when released. For example,closure element 500 can have a natural, planar configuration withopposing tines and a natural cross-section. The closure element can beformed from any suitable material, including any biodegradable material,any shape memory material, such as alloys of nickel-titanium, or anycombination thereof. Additionally, it is contemplated that the closureelement may be coated with a beneficial agent or be constructed as acomposite, wherein one component of the composite would be a beneficialagent. As desired, the closure element may further include radiopaquemarkers (not shown) or may be wholly or partially formed from aradiopaque material to facilitate observation of the closure elementusing fluoroscopy or other imaging systems. Exemplary embodiments of aclosure element are disclosed in U.S. Pat. Nos. 6,197,042, 6,623,510,6,461,364, 6,391,048, and 6,719,777 and U.S. Patent Publication Nos.2004-153122 and 2004-039414. The disclosures of these references and anyothers cited therein are expressly incorporated herein by reference.

It will be appreciated that the closure element may be constructed ofother materials, that it may include alternative shapes, and that it mayadopt alternative methods of operation such that the closure elementachieves closure of openings in blood vessel walls or other body tissue.In an additional non-limiting example, the closure element isconstructed of materials that use a magnetic force to couple a pair ofsecuring elements in order to close an opening in the lumen wall ortissue. In this alternative embodiment, the closure element may be of aunitary or multi-component construction having a first securing elementpositionable at a first position adjacent the opening, and a secondsecuring element positionable at a second position adjacent the opening.The first and second securing elements are provided having a magneticforce biasing the first and second securing elements together, therebyclosing the opening, or they are provided having a magnetic forcebiasing both the first and second securing elements toward a thirdsecuring element positioned in a manner to cause closure of the opening.The magnetic closure element may be provided without tines, provided themagnetic force coupling the closure elements is sufficient to close theopening. Alternatively, the closure element may be provided with acombination of the magnetic securing elements and tines to provide acombination of coupling forces. Those skilled in the art will recognizethat other and further materials, methods, and combinations may beutilized to construct the closure element to achieve the objectivesdescribed and implied herein.

As described previously, and with reference to FIG. 15A, closure element500 may be disposed within the carrier assembly and adjacent to thedistal end of pusher tube 320. As shown in FIG. 15A, for example, thereduced closure element 500 may be slidably received overdistally-increasing cross-section of distal end region of carrier member310 and may be disposed about periphery 312 of carrier member 310adjacent to space 360. Since reduced cross-section 530 of reducedclosure element 500 is less than cross-section of distally-increasingcross-section, reduced closure element 500 may be temporarily radiallydeformed to be received over distal end region of the carrier member310. Also, as reduced closure element 500′ (FIG. 14C) is received overdistal end region of carrier member 310, opposing tines 520 of reducedclosure element 500′ (FIG. 14C) engage distal end region of carriermember 310. Reduced closure element 500′ (FIG. 14C) may thereby formsubstantially tubular closure element 500″, illustrated in FIG. 14G,with the ends of the barbs and/or tines extending towards the distal endof the apparatus 100.

The apparatuses of the present invention may be configured to beutilized with a sheath. The sheath may be inserted or otherwisepositioned into an opening in a body having a lumen. The sheath maygenerally have a substantially flexible or semi-rigid tubular memberhaving a proximal end region and a distal end region and may include apredetermined length and/or a predetermined cross-section, both of whichcan be of any suitable dimension. The sheath may form a lumen that mayextend along a longitudinal axis of the sheath and/or substantiallybetween the proximal and/or distal end regions. The lumen may have anysuitable internal cross-section and may be suitable for receiving one ormore devices (not shown), such as a catheter, a guide wire, and/or otherdevice. The lumen may be configured to slidably receive the tubular bodyof the locator assembly and/or the tube set of the carrier assembly ofthe devices in accordance with the present invention.

Since the internal cross-section of the sheath may be less than orsubstantially equal to the predetermined cross-section of the covermember, the sheath may be configured to radially expand, such as bystretching, to receive the tube set. Alternatively, or in addition, thesheath may be advantageously configured to split as the tube set isreceived by and advances within the lumen of the sheath. This may permitthe apparatuses to access the body lumen wall. To facilitate thesplitting, the sheath may include one or more splits, such aslongitudinal splits. Each split may be configured to split the sheath inaccordance with a predetermined pattern, such as in a spiral pattern. Itwill be appreciated that when the internal cross-section of the sheathis greater than the predetermined cross-section of the cover member, itmay not be necessary for the sheath to be configured to radially expandand/or split. In some embodiments, the apparatus may include a cuttingmeans that initiates a tear line or split in the sheath when the sheathis engaged with the distal end of the apparatus.

The sheath may be advanced over a guide wire or other rail (not shown),which has been positioned through the opening and into the blood vesselusing conventional procedures such as those described above. In someembodiments, the blood vessel may be a peripheral blood vessel, such asa femoral or carotid artery. In other embodiments, other body lumens maybe accessed using the sheath. The opening, and consequently the sheath,may be oriented with respect to the blood vessel to facilitate theintroduction of devices through the lumen of the sheath and into theblood vessel with minimal risk of damage to the blood vessel. One ormore devices (not shown), such as a catheter, a guide wire, and/or otherdevices, may be inserted through the sheath and/or advanced to apreselected location within the patient's body. For example, the devicesmay be used to perform a therapeutic and/or diagnostic procedure, suchas angioplasty, atherectomy, stent implantation, and/or otherprocedures, within the patent's vasculature.

FIGS. 15A-K illustrate one exemplary manner to deploy closure element500 by apparatuses according to the present invention. For purposes ofcontinuity, reference numbers to the first discussed embodiment areused, but it will be evident that other embodiments discussed above maybe used in a similar fashion.

A sheath 640 may be inserted or otherwise positioned through a patient'sskin 650 and tissue 630 and within the blood vessel 600 or other bodylumen via the opening 610. This provides access to the blood vessel 600through the blood vessel wall 620 for performance of a therapeutic ordiagnostic procedure. The sheath 640 will be described in more detailbelow.

After the procedure is completed, the devices associated with thetherapeutic or diagnostic procedure are removed from sheath 640, andapparatus 100 can be prepared to be received by lumen 644 of the sheath.Being in the unexpanded state, the distal end region 210 b of tubularbody 210 of the locator assembly 200 can be slidably received by thelumen and atraumatically advanced distally into the blood vessel 600, asillustrated in FIG. 15B. Once the distal end region 210 b extends intoblood vessel 600, distal end region 210 b can transition from theunexpanded state to the expanded state by activating the switchingsystem of locator assembly 200, and as illustrated in FIG. 15C. Asdiscussed with reference to the embodiments described in reference toFIGS. 9-13, the carrier assembly may be partially advanced when thelocator assembly is transitioned from the unexpanded to the expandedstate by pressing the locator assembly block distally with respect tothe housing.

Turning to FIG. 15D, apparatus 100 and/or sheath 640 can then beretracted proximally until distal end region 210 b is substantiallyadjacent to an outer surface 620 a of blood vessel wall 620. Distal endregion 210 b thereby draws blood vessel wall 620 taut and maintains theproper position of apparatus 100 as blood vessel 600 pulsates. Since theexpanded cross-section of distal end region 210 b is greater than orsubstantially equal to the cross-section of opening 610 and/or thecross-section of lumen 644, distal end region 210 b remains in bloodvessel 600 and engages inner surface 620 b of blood vessel wall 620.Distal end region 210 b can frictionally engage inner surface 620 b ofblood vessel wall 620, thereby securing apparatus 100 to blood vessel600. Sheath 640 can be retracted proximally such that distal end region640 b of sheath 640 is substantially withdrawn from blood vessel 600,permitting apparatus 100 to access blood vessel wall 620.

Once distal end region 210 b of locator assembly 200 contacts innersurface 620 b of blood vessel wall 620, tube set 305 can then beadvanced distally and received within lumen 644 of sheath 640. In themanner described above, sheath 640 can radially expand and/or split inaccordance with the predetermined pattern as tube set 305 advancesbecause the internal cross-section of sheath 640 is less than orsubstantially equal to pre-determined cross-section 338 b of covermember 330. Being coupled, carrier member 310, pusher member 320, covermember 330, and support member 340 each advance distally and approachthe first predetermined position, as illustrated in FIG. 15F. Asdiscussed with reference to the embodiments described in reference toFIGS. 9-13, a stable base can be provided by handle portion 1600 havingan enlarged, curved configuration that can receive at least a thumb orfinger of the physician. The enlarged, curved handle portion 1600 cangripped by the physician while the physician's hand is rested upon apatient during the procedure and provide stability during use of thedevice. Additionally, the combined deployment of locator assembly 1110and the partial advancement of carrier assembly 1120 in a single stepallows for a reduction in travel of trigger extension 1405. Thus, a userdoes not need to reach uncomfortably far from handle portion 1602 totrigger extension 1405 to fully advance carrier assembly 1120 and thetube set coupled to the carrier assembly.

Upon reaching the first predetermined position, tube set 305 is disposedsubstantially adjacent to outer surface 620 a of blood vessel wall 620adjacent to opening 610 such that the blood vessel wall adjacent toopening 610 is disposed substantially between expanded distal region 210b of locator assembly 200 and tube set 305. Support member 340 decouplesfrom carrier member 310 and pusher member 320 in the manner describedabove when tube set 305 is in the first predetermined position. Thecover member 330 and pusher member 320 are advanced. After advancement,the cover member 330 is decoupled from the carrier member 310 and pushermember 320. Thereby, cover member 330 and support member 340 may beinhibited from further axial movement and remain substantiallystationary as carrier member 310 and pusher member 320 each remaincoupled and axially slidable.

As shown in FIG. 15G, cover member 330 and support member 340 remainsubstantially stationary while carrier member 310 and pusher member 320continue distally and approach the second predetermined position. Ascarrier member 310 and pusher member 320 distally advance toward thesecond predetermined position, annular cavity 370 moves distallyrelative to substantially-stationary cover member 330 such that distalend region 330 b of cover member 330 no longer encloses annular cavity370. Thereby, closure element 500 is not completely enclosed by annularcavity 370 formed by distal end regions 310 b, 320 b, and 330 b ofcarrier member 310, pusher member 320, and cover member 330.

Although not completely enclosed by annular cavity 370, substantiallytubular closure element 500 is advantageously retained on outerperiphery 312 b of carrier member 310 by distal end region 330 b ofcover member 330 as illustrated in FIG. 15G. For example, by retainingsubstantially tubular closure element 500 between distal end region 330b of cover member 330 and distal end region 310 b carrier member 310,apparatus 100 may be configured to provide better tissue penetration.The timing between the deployment of substantially tubular closureelement 500 by tube set 305 and the retraction and transition to theunexpanded state by locator assembly 200 likewise is facilitated becausesubstantially tubular closure element 500 is retained between distal endregion 330 b and distal end region 310 b. Further, carrier member 310and cover member 330 operate to maintain substantially tubular closureelement 500 in the tubular configuration.

When tube set 305 is in the second predetermined position, carriermember 310 decouples from pusher member 320 in the manner described indetail above. Therefore, carrier member 310, cover member 330, andsupport member 340 may be inhibited from further axial movement andremain substantially stationary, whereas, pusher member 320 remainsaxially slidable. As pusher member 320 continues distally, distal endregion 320 b of pusher member 320 contacts substantially tubular closureelement 500 and displaces substantially tubular closure element 500 fromspace 360 as shown in FIG. 15H. Since space 360 is substantiallyradially exposed, pusher member 320 directs substantially tubularclosure element 500 over the distally-increasing cross-section of distalend region 310 b of substantially-stationary carrier member 310 suchthat the cross-section of substantially tubular closure element 500begins to radially expand, preferably in a substantially uniform manner.As substantially tubular closure element 500 traverses the distallyincreasing cross-section of distal end region 310 b, the cross-sectionof substantially tubular closure element 500 radially expands beyondnatural cross-section of closure element 500, as shown in FIGS. 14A-G.

Upon being directed over the distally increasing cross-section of distalend region 320 b by pusher member 320, substantially tubular closureelement 500 is distally deployed as illustrated in FIG. 15I. Whensubstantially tubular closure element 500 is deployed, tines 520 canpierce and otherwise engage significant amount of blood vessel wall 620and/or tissue 630 adjacent to opening 610. For example, tines 520 canengage significant amount of blood vessel wall 620 and/or tissue 630because cross-section 530 of substantially tubular closure element 500is expanded beyond natural cross-section 530 of closure element 500during deployment.

As closure element 500 is being deployed from the space, locatorassembly 200 may begin to retract proximally and locator release system490 can be activated to transition from the expanded state to theunexpanded state as substantially tubular closure element 500 isdeployed. Distal end region 210 b of locator assembly 200 may retractproximally and transition from the expanded state to the unexpandedstate substantially simultaneously with the deployment of substantiallytubular closure element 500. As desired, distal end region 210 b may beconfigured to draw blood vessel wall 620 and/or tissue 630 adjacent toopening 610 proximally and into the channel defined by substantiallytubular closure element 500. Tines 520 of substantially tubular closureelement 500 thereby can pierce and otherwise engage blood vessel wall620 and/or tissue 630.

Turning to FIGS. 15J and 15K, substantially tubular closure element 500,once deployed, begins to transition from the tubular configuration,returning to the natural, planar configuration with opposing tines 520and a natural cross-section of closure element 500. Preferably,substantially tubular closure element 500 substantially uniformlytransitions from the tubular configuration to the natural, planarconfiguration. Rotating axially inwardly to form opposing tines 520 ofthe closure element 500, tines 520 draw the tissue into the channel assubstantially tubular closure 500 element forms closure element 500.Also, the tissue is drawn substantially closed and/or sealed as thecross-section of substantially tubular closure element 500 contracts toreturn to the natural cross-section.

Turning to FIGS. 16A and 16B, embodiments of the apparatus 100, 1000 ofthe present invention may be configured to be utilized with sheath 640.Sheath 640 may be inserted or otherwise positioned into an opening in abody having a lumen. Sheath 640 generally has a substantially flexibleor semi-rigid tubular member having a proximal end region 640 a and adistal end region 640 b and includes a predetermined length and apredetermined cross-section, both of which can be of any suitabledimension. Sheath 640 forms lumen 644 that extends along a longitudinalaxis of sheath 640 and substantially between the proximal end region 640a and the distal end region 640 b. Lumen 644 can have any suitableinternal cross-section and is suitable for receiving one or more devices(not shown), such as a catheter, closure device, apparatus 100, 1000, orthe like. Lumen 644 can be configured to slidably receive the tubularbody 210 of locator assembly 200 and/or tube set 305 of the devices inaccordance with the present invention. Sheath 640 may be formed fromdifferent materials as discussed herein.

Since the internal cross-section of sheath 640 may be less than orsubstantially equal to the predetermined cross-section of cover member330 (FIG. 1A) of apparatus 100, sheath 640 may be configured to radiallyexpand, such as by stretching, to receive tube set 305 (FIG. 1A).Alternatively, or in addition, sheath 640 may be advantageouslyconfigured to split as tube set 305 is received by, and advances withinlumen 644 of sheath 640, thereby permitting the apparatus to accessblood vessel wall 620. To facilitate the splitting, sheath 640 caninclude one or more splits, such as longitudinal splits 634. Each splitmay be configured to split sheath 640 in accordance with a predeterminedpattern, such as in a spiral pattern, one exemplary embodiment of whichis shown in FIG. 25B. It will be appreciated that, when the internalcross-section of sheath 640 is greater than the predeterminedcross-section of cover member 330, it may not be desirable for sheath640 to be configured to radially expand and/or split. In addition to, oralternatively, the apparatus 100 may include a cutting member, such assheath cutter 701 shown in FIG. 2, that initiates a tear line or splitin sheath 640 when sheath 640 is engaged with the distal end of theapparatus.

Sheath 640 may be advanced over a first guidewire or other rail (notshown), which has been positioned through the opening and into bloodvessel 600 using conventional procedures such as those described above.In one configuration, blood vessel 600 is a peripheral blood vessel,such as a femoral or carotid artery, although other body lumens may beaccessed using sheath 640. After the first guidewire or other rail isremoved from lumen 644 and vessel 600, the opening, and consequentlysheath 640, may be oriented with respect to blood vessel 600 such as tofacilitate the introduction of devices through lumen 644 of sheath 640and into blood vessel 600 with minimal risk of damage to blood vessel600. One or more devices (not shown), such as a catheter, or the like,may be inserted through sheath 640 and advanced to a preselectedlocation within the patient's body. For example, the devices may be usedto perform a therapeutic or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patent'svasculature.

Sheath 640 may contain a secondary channel 670 formed in the perimeterwall 660 of sheath 640 through which a second guidewire 690 can beinserted. Secondary channel 670 may include a proximal entrance 670 anear a hub portion 655 of sheath 640 as well as a distal exit 670 b nearthe distal end of sheath 640. With sheath 640 already inserted into abody lumen, such as a blood vessel 600, second guidewire 690 can then beinserted into proximal entrance 670 a and exit through distal exit 670 bof secondary channel 670, into the body lumen. The secondary channel 670may further include a valve or membrane to form a fluid tight seal torestrict fluid flow through the second channel 670 if a second guidewire690 is not disposed therein. Lumen 644 of sheath 640 would, therefore,remain open for closure element 500 to be advanced through tube set 305.Upon deployment of closure element 500, second guidewire 690 may bepositioned adjacent to the substantially planar closure element 500 andtherefore remain within the body lumen and allow re-access to the site,if necessary.

Therefore, the second guidewire 690 may be used to re-access the site ofthe body lumen puncture in the patient if other complications arise uponclosing of closure element 500. When second guidewire 690 is no longerneeded, it may be removed from the lumen without disturbing the closureelement.

The sheath 640 may be used in varying guidewire configurations. Forexample, a first guidewire may be inserted through the lumen 644, thesheath 640 may be inserted into a body lumen, i.e. the blood vessel 600,and the tube set 305 of the apparatus 100 may be advanced through thelumen 644, as described above. However, if the tube set 305 is largerthan the lumen 644, the guidewire may be pushed through a wall (notshown) of the sheath 640 and into the secondary channel 670 making roomfor the tube set 305.

Referring now to FIG. 17, there is shown an exemplary embodiment of anintroducer sheath 2100. The introducer sheath 2100, like the introducersheath 640 described above, can include a hub portion 2102, which caninclude a proximal end 2116 and a distal end 2114, and a tubular portion2104. Extending from the proximal end 2116 toward the distal end 2114 isa lumen 2110. This lumen 2110 can cooperate with a medical device (notshown), such as a vessel closure device, insertable therethrough. In theillustrated configuration, the lumen 2110 tapers or transitions from onecross-sectional configuration to another cross-sectional configurationnear the distal end 2114 to meet or intersect with a lumen 2112 of thetubular portion 2104. It will be understood that the lumen 2110 can havea generally uniform cross-section along its length rather than taperingat its distal end. More generally, the lumen 2110 can include one ormore transitional portions based upon the desired configuration and/oruse with other medical devices.

The elongated tubular portion 2104 of the introducer sheath 2100 canextend from the distal end 2114 of the hub portion 2102. The tubularportion 2104 can include a distal end 2120 and a proximal end 2118. Theproximal end 2118 can be integrally formed with the distal end 2114 ofthe hub portion 2102 or can be mounted or coupled to the distal end 2114through a friction fit, mechanical bonding, adhesives, thermal orchemical bonding, combinations thereof or other manufacturing techniqueusable to mount, couple or attach two medical components. The distal end2120 of the tubular portion 2104 can optionally include a taperedportion 2106 to facilitate insertion into a body lumen. This taperedportion 2106 may be formed during or after the initial forming processof the introducer sheath 2100. For instance, when the introducer sheath2100 is formed through a molding or extrusion process, the taperedportion 2106 can be formed as part of this process. Alternatively, thetapered portion 2106 may be formed by heat forming, grinding or otherknown methods that result in a thinner wall thickness following theabove-described molding or extrusion process or as part of a milling,machining, or similar process.

Optionally disposed at the transition between the hub portion 2102 andthe tubular portion 2104 is a strain relief portion 2108. The strainrelief portion 2108 would be disposed adjacent the distal end 2114 ofthe hub portion 2102 and adjacent the proximal end 2118 of the elongatetubular portion 2104. The strain relief 2108 would be configured toprovide additional support to the proximal end 2118 of the elongatedshaft 2104 to prevent kinking at the transition between the proximal end2118 of the elongated member 2104 and the distal end 2114 of the hubportion 2102. In one embodiment, the strain relief portion 2108 can beformed by gradually increasing a thickness of tubular portion 2104 atthe transition between the tubular portion 2104 and the hub portion2102. In other configurations, the strain relief portion 2108 caninclude webs, extensions, or other internal or external structures toincrease the strength and/or stiffness of the introducer sheath 2100 atthe hub portion/tubular portion transition.

The tubular portion 2104 of the introducer sheath can be expandable.More specifically, in the illustrated configuration of FIG. 17, thetubular portion 2104 is of an elastomeric material that allows thediameter of the tubular portion 2104 to change as a medical device isinserted or removed from within the lumen 2112. The elastomeric materialenables the tubular portion 2104 to expand/contract or deform/reform,while maintaining sufficient column stiffness or strength so that theintroducer sheath 2100 can be inserted into the body lumen. In oneconfiguration, the elastomeric material can be any of those describedherein and such others as would be identified by one skilled in the artin light of the teaching contained herein.

Optionally, the tubular portion 2104 may also be configured to expand toa certain diameter at which point the tubular portion 2104 is furtherconfigured to split or separate into one or more portions to accommodateother medical devices, such as, but not limited to vessel closuredevices, as will be described in more detail hereinafter.

Generally, each of the hub portion 2102 and the tubular portion 2104 canhave at least a portion of which that is generally cylindrical innature. Although portions 2102 and 2104 can have generally cylindricalportions, other cross-sectional configurations are possible, such as butnot limited to, oval, polygonal, elliptical, or other cross-sectionalconfigurations usable for a medical device that is insertable into abody lumen.

As previously described herein, the introducer sheath 2100 may be formedthrough an injection molding process. In an injection molding process,the hub portion 2102 and the elongated tubular portion 2104 aregenerally formed as a unitary member. Benefits of forming the introducersheath 2100 as a unitary member include reduced costs, increasedaccuracy of part dimensions (i.e. dimension control) due to lack ofassembly, alignment between the lumen 2112 of the tubular portion 2104and the lumen 2110 of the hub portion 2102, and the balancing ofmechanical properties across the entire sheath 2100 or of any particularportion or member of the sheath 2100. The thickness of the walls of thehub portion 2102 and/or of the tubular portion 2104 can also becontrolled and varied as desired during the injection molding process.

Although reference is made herein to fabrication of the introducersheath 2100 through use of injection molding techniques, one skilled inthe art will appreciate that various other techniques can be used. Forinstance, the introducer sheath can be fabricated using milling,grinding, laser treatment, etching, or other techniques to form theintroducer from a piece of material. Further, other techniques ormethods can include those techniques used by those skilled in the art tofabricate medical devices.

With continued reference to FIG. 17, disposed within the hub portion2102 is a flexible valve member 2122 disposed in the hub portion 2102.The valve member 2122 may be integrally formed into the hub portion 2102during the molding process of the sheath 2100, or may be inserted afterthe sheath 2100 is integrally formed. For instance, the hub portion 2102can included a receiving feature 2126, such as a groove or channel, toreceive the valve member 2122. The cooperation between the receivingfeature 2126 and the valve member 2122 result in a sealed hub portion2102. Stated another way, the valve member 2122 is self-sealing once itis inserted into the hub portion 2102 to prevent fluid escaping from thebody lumen.

The valve member 2122 can be a seal and can have a variety of differentconfigurations to seal the sheath 2100. The valve member 2122, forexample, may have an elastomeric body, such as silicone rubber, with atleast one slit and/or other collapsible openings formed therein to allowselective insertion and removal of medical devices or instruments, suchas guidewires, catheters, balloon pumps, and other such devices. At thesame time, the material and/or structure of the valve member 2122maintains a fluid tight seal around the medical devices or instruments.Thus, blood or other bodily fluids are prevented from leaking out, andunwanted air is prevented from entering into the body.

It will be understood that the valve member 2122 can be mounted orcoupled to the hub portion 2102 in a number of other manners to achievethe sealed configuration for the hub portion 2102. For instance, thevalve member 2122 can be retained with a retaining cap (not shown)disposed adjacent the proximal end of the hub portion 2102. In stillanother configuration, one or more flexible valves or valve members canbe mounted within or to the proximal end 2116 of the hub portion 2102 byone or more retaining caps, rings, or members know to those skilled inthe art. Although illustrated as a single member, the valve member 2122can be formed of multiple parts to provide the desired fluid sealingcapabilities. Exemplary flexible membranes or valve members, which canbe utilized with the present invention, are shown in U.S. Pat. Nos.4,798,594, 5,176,652, and 5,453,095 the entireties of which are hereinincorporated by reference.

More generally, the introducer sheath can have a configuration similarto the introducer sheath disclosed in U.S. Provisional PatentApplication Ser. Nos. 60/659,602 entitled “Introducer Sheath”; and60/695,464 entitled “Modular Introducer Sheath; and co-pending U.S.patent application Ser. No. 11/427,301, filed Jun. 28, 2006, andentitled “Modular Introducer and Exchange Sheath” and Ser. No.11/427,306, filed Jun. 28, 2006, and entitled “Expandable IntroducerSheath”), the disclosures of which are herein incorporated by reference.As such, the valve member 2122 can be mounted in the hub portion 2102and the tubular portion 2104 can have a similar configuration to thetubular member to the introducer sheath described in theabove-identified applications.

FIG. 17 also illustrates an optional port member 2124, such as a luerport/fitting, which may be formed on the hub portion 2102. The portmember 2124 may function as a fluid port for the sheath 2100. Fluid(e.g., blood, antibiotics, plasma, saline, etc.) can thus be introducedand/or extracted through the fluid port 2124. The port member 2124 mayalso be optionally configured to align and/or selectively lock anydevice (e.g., a vessel closure device, a catheter) used in conjunctionwith the sheath 2100.

FIGS. 18-21 and 23-26 generally illustrate various configurations of thetubular body of the introducer sheath of the present invention. Duringthe insertion/extraction of a medical device or instrument, the tubularbody can deform/form or expand/contract as needed. Thus, thecross-sectional area of the tubular body may change during a medicalprocedure. In one example, the tubular body can expand in diameter froma first position to a second position having a diameter greater than thefirst position as a medical device is either withdrawn or insertedtherethrough. The tubular body can also return to or substantially tothe first position following withdrawal or insertion. The illustratedconfigurations of the tubular body each have a sheath portion and anelastic portion to provide the desired elasticity, stiffness, orstrength. The sheath portion and the elastic portion can be formed fromdifferent materials as illustrated in FIGS. 18-20 discussed below.Alternatively, and as illustrated in FIG. 21, the tubular body can befabricated from a single material, with the elastic portions beingdefined through the formation of lumens in the tubular body. Theinclusion of lumens or of elastomeric materials in the formation of anintroducer sheath enable the sheath to deform/form or expand/contract asdescribed herein.

Although various features are illustrated in each Figure, any of thefeatures in a particular Figure can be combined with featuresillustrated in another Figure. Further, the sheath portion and/orelastic portion are examples of one structure capable of performing thefunction of means for expanding a tubular body to accommodate theinsertion or removal of a medical device.

Turning now to FIG. 18, illustrated is a tubular body, identified byreference numeral 2200, which can be used with the introducer sheath ofthe present invention, i.e., can function as the tubular body 2104 ofFIG. 17, i.e., function to expand/contract or deform/reform to enablewithdrawal of a medical device that may have enlarged in diameter duringuse. The tubular body 2200 can include at least one sheath portion 2204and at least one elastic portion 2202. The sheath portion 2204 istypically formed of a first material and the elastic portion 2202 isoften formed of a second material. In FIG. 18, the sheath portion 2204can be formed in strips that run along the length of the tubular body2200 from the distal end 2220 to the proximal end 2218, although thestrips may have a shorter length. In some embodiments, the strips extendinto the distal end 2114 (FIG. 17) of the hub portion 2102 (FIG. 17).The elastic portion 2202 can be formed in strips in this embodiment suchthat each strip of the elastic portion 2202 is adjacent to strips of thesheath portion 2204.

The elastic portion 2202 can be an elastomer that is bonded to thesheath portion 2204. In FIG. 18, each strip of the elastic portion 2202is bonded on each side to adjacent strips of the sheath portion 2204.The elastic portion 2202 enables the tubular body 2200 to expand ordeform such that the interior diameter or cross-sectional area of thelumen can change or increase. The diameter or cross-sectional area ofthe lumen 2212 can expand in certain locations and is not required toexpand along the entire length of the tubular body 2200. Further,different portions of the tubular body 2200 may expand at differentrates and/or at different times. The actual expansion of the tubularbody 2200 can depend on a particular medical device that is inserted orwithdrawn and/or the material used to form the tubular body 2200. Thesheath portion 2204 can be selected to ensure that the lumen does notcollapse when the tubular body 2200 is in a first, normal, or unstressedposition and to provide stiffness or rigidity to the tubular body 2200.Thus, the sheath portion 2204 provides rigidity, flexibility, and thelike or any combination thereof. In some embodiments, the sheath portion2204 may also provide some elasticity to the tubular body 2200.Typically, however, the elastic portion 2202 has more elasticity thanthe sheath portion 2204.

FIG. 18 also illustrates an optional entry portion 2228 to the lumen2212 of the tubular body 2200. The entry portion 2228 can be shaped tofacilitate entry of any device that is entering the tubular body 2200through the entry portion 2228. The entry portion 2228 can be formedwhen the tapered portion 2206 is formed and the slope of the taperedportion 2206 may be optionally altered to accommodate the entry portion2228. By shaping the entry portion 2228, any device being withdrawn canmore easily enter the lumen 2212 of the tubular body 2200. In oneembodiment, the entry portion 2228 is concave and the edges at thedistal end of the tubular body 2200 are smoothed. In otherconfigurations, the entry portion 2228 can be generally curved, smooth,or other configuration to aid with withdrawal of a medical device intothe lumen 2212.

The elongated tubular body 2200 can include an outer wall 2208 and aninner wall 2210 thereby defining a wall and a thickness of the wall. Aswith the lumen 2112 (FIG. 17), the lumen 2212 extends along the lengthof the tubular body 2200. The width, diameter, or cross-sectional areaof the lumen 2212 can vary and may depend on intended use of the sheath2100. More particularly in this embodiment, the width or diameter orcross-sectional area of the lumen 2212 can vary or expand and contractduring use as the elastic portion 2202 changes shape, such as stretchingand contracting. Because the hub portion 2102 (FIG. 17) and the tubularbody 2200 are integrally formed in one configuration, the lumen 2212 ofthe tubular body 2200 remains aligned with the lumen 2110 (FIG. 17) ofthe hub portion 2102 (FIG. 17) even though the lumen 2212 expands,contracts, deforms, or reforms. It is contemplated that the wallthickness along the length of the elongated tubular body 2200 can bevaried to vary mechanical properties of the sheath (stiffness, kinkresistance, column strength, etc.).

FIG. 19 illustrates a cross section of the tubular body 2200 of theintroducer sheath as it moves from first, normal, or unstressed positionto a second, expanded, or stressed position of the tubular body 2200. Inthe first position, identified by reference letter A, the elasticportion 2202 of the tubular body 2200 is in a contracted or relaxedstate and is bonded to the material of the sheath portion 2204 at thebond points 2230. The sheath portion 2204 can be typically formed from amaterial such that the lumen 2212 of the tubular body 2200 does notseal, close, or collapse in the first position, and/or to providestiffness or flexibility to the tubular body 2200.

In the second position, identified by reference letter B, the elasticportion 2202 is expanded while the sheath portion 2204 has not expanded(or has expanded less than the elastic portion 2202) but is still bondedto the material at the bonds 2230. In one embodiment, the sheath portion2204 may have some elasticity, but is generally configured to have lesselasticity than the elastic portion 2202. The bond strength at the bond2230 may be selected to permit the expansion of the tubular body 2200 toa predetermined diameter or by a predetermined amount. When thatdiameter or amount is exceeded, the tubular body 2200 may split at thebonds 2230 or at another location.

In some embodiments, a geometric pattern 2232 is formed on the innerwall 2210 or inner surface of the tubular body 2200, such as over all orat least one portion of the inner wall 2210 or inner surface. Further,the geometric pattern 2232 can be formed in or on the elastic portion2202 and/or the sheath portion 2204. This geometric pattern 2232 can beused to impart certain desirable mechanical properties to the tubularbody 2200, such as, but not limited to, stiffness, strength, kinkresistance, or flexibility to the tubular body 2200.

Various structures and configurations of the geometric pattern 2232 canbe used to provide the desired mechanical properties. For instance, inthe illustrated configuration, the geometric pattern 2232 is formed onone portion or surface of the inner wall 2210 of the sheath portion 2204though use of one or more grooves or recesses. The illustrated geometricpattern 2232 can represent a plurality of longitudinal grooves extendingalong an axis parallel to the longitudinal axis of the introducer sheathin a generally uniformly distributed pattern. In other configurations,however, the geometric pattern 2232 can be unevenly distributed or acombination of uniformly and unevenly distributed over all or a portionof the inner wall 2210 of the tubular body 2200. Further, the locationof the grooves need not be parallel to the longitudinal axis of theintroducer sheath, but can be transverse to such an axis and/or at anyother angular orientation relative to the longitudinal axis.

It shall be understood that the pattern 2232 as shown in FIG. 19 shouldbe considered exemplary and not limiting in any manner. It iscontemplated that additional styles and types of patterns may beutilized in accordance with the present invention. For example, thepattern 2232 may be a sinusoidal pattern disposed about the inner radiusof the tubular body 2200. Alternatively, the pattern 2232 may beconfigured to run along a different axis than one parallel to thelongitudinal axis of the introducer sheath. For example, the pattern2232 may be formed as a spiral. The pattern 2232 may also only extendpartially along the length of the tubular body 2200.

Further, the pattern 2232 can extend along the length of the tubularbody 2200 from the proximal end 2218 to the distal end 2220 or along aportion of the length of the tubular body 2200. The pattern 2232, or anyportion thereof, may terminate prior to the proximal end 2220 of thetubular body 2200 or extend partially into the hub portion 2102 (FIG.17). The pattern 2232 may also be a separation line, such as apre-scored line. The pattern 2232 may be designed to facilitatesplitting of at least a portion of the introducer sheath. For example,the introducer sheath may split along all or a portion of the geometricpattern 2232 after expanding past a predetermined limit.

FIG. 20 illustrated is a cross section view of another tubular body ofan introducer sheath. This tubular body 2300 can be used with theintroducer sheath 2100 (FIG. 17) and function to expand/contract ordeform/reform to enable withdrawal of a medical device that may haveenlarged in diameter during use. The tubular body 2300 has a similarconfiguration to that of tubular body 2200, and, as such, thedescription related to tubular body 2200 also applies to tubular body2300. As with tubular body 2200, the tubular body 2300 includes at leastone elastic portion 2302 and at least one sheath portion 2304. Theelastic portion 2302 and the sheath portion 2304 are mechanicallycoupled and/or bonded together to provide additional strength to theconnection or coupling between the elastic portion 2302 and the sheathportion 2304. For instance, in addition to or instead of a thermal orchemical bond between the elastic portion 2302 and the sheath portion2304, a mechanical connection is made between the portions 2302 and 2304to maintain the coupling or attachment of the elastic portion 2302 andthe sheath portion 2304.

In the illustrated configuration of FIG. 20, the mechanical coupling orconnection is facilitated by way of at least one interlocking feature2306 that cooperates and mechanically engages with a correspondingrecess or receiving portion of the sheath portion 2304. Eachinterlocking feature 2306 can include at least one extension 2308, whichextends from the main body of the elastic portion 2302, and at least onprotrusion 2310 extending from an end of the extension 2308. With the atleast one protrusion 2310 extending from and being generally transverseto the extension 2310, the at least one protrusion 2310 aids withpreventing detachment of the elastic portion 2302 from the sheathportion 2304 as the tubular body 2300 extends/contract ordeforms/reforms. Although reference is made to the at least oneprotrusion 2310 extending transverse to the at least one extension 2308,one skilled in the art will appreciate that the at least one protrusion2310 can extend from the at least one extension 2308 are other angularorientations while still being capable of preventing detachment.

The at least one interlocking feature 2306 illustrated in FIG. 20 canextend from a proximal end to a distal end of the tubular body 2300and/or the introducer sheath. It will be understood, however, that theat least one interlocking feature 2306 can extend only part way from thedistal end toward the proximal end, from the proximal end to the distalend, or at any location along the length of the tubular body 2300.Similarly, although the interlocking feature 2306 is illustrated asextending from the elastic portion 2302 toward the sheath portion 2304,it will be understood that the corresponding recess or receiving portionof the sheath portion 2304 can also be considered an interlockingfeature. Further, the elastic portion 2302 can be configured with thecorresponding recess or receiving portion, while the sheath portion 2304includes the at least one extension 2308 and/or the at least oneprotrusion 2310.

The interlocking feature 2306 of the tubular body 2300 of FIG. 20 can beformed during the manufacturing process of the introducer sheath. Forinstance, the interlocking feature 2306, with the corresponding recessor receiving portion, can be formed during injection molding or during aco-extrusion process of the tubular body 2300 and/or the introducersheath. Alternatively, the interlocking feature 2306 can be formedduring manufacture of the elastic portion, such as by injection moldingor a co-extrusion process, with the elastic portion being subsequentlybonded or coupled to the sheath portion, or vice versa, through thermalbonding, chemical bonding, or other known technique to bond similar ordissimilar medical grade materials.

Turning now to FIG. 21, illustrated is a cross section view of anothertubular body of an introducer sheath. This tubular body 2400 can be usedwith the introducer sheath 2100 (FIG. 17) and function toexpand/contract or deform/reform to enable withdrawal of a medicaldevice that may have enlarged in diameter during use.

FIG. 21 illustrates a cross section of the tubular body 2400 of theintroducer sheath as it moves from a first, normal, or unstressedposition to a second, expanded, or stressed position of the tubular body2400. In the first position, again identified by reference letter A, thetubular body 2400 is in a contracted or relaxed state. The tubular body2400 is similar to the tubular body 2104 (FIG. 17), but further includesa plurality of lumens 2420 disposed at least partially in a wall 2422defined by an outer wall 2408 and an inner wall 2410 of the tubular body2400. The region of the tubular body 2400 containing the plurality oflumens 2422 has a smaller wall thickness than the remainder of thetubular body 2400. These regions of smaller wall thickness function aselastic portions 2402 of the tubular body 2400, while those regions ofthe wall 2422 having no lumens 2422 function as the sheath portion 2404.Stated another way, the inclusion of the plurality of lumens 2422provides elasticity, expandability, or deformability to the tubularmember 2400 at the elastic portions 2402. The number of lumens 2422 inthe tubular body 2400 can vary based upon the degree of flexibilitydesired for the tubular body 2400. Further the particular size,cross-sectional shape, and/or ratio of lumen cross-sectional area toarea of the wall can be varied to obtain different column strength,stiffness, kink resistance, elasticity, deformability, or otherdesirable mechanical properties or characteristics of the tubular member2400.

In the expanded position, identified by reference letter B, the at leastone lumen 2422 enables the relatively thinner wall portions of thetubular member 2400 to stretch, thereby increasing the cross-sectionalarea or shape of the tubular body 2400. After expansion, the tubularbody 2400 can return to the first position.

Generally, by forming the tubular body as a composite member usingmaterials having the desired elastic properties, whether or not thetubular body includes at least one lumen to increase the elasticity,expandability, or deformability of the tubular body, mechanicalproperties of the tubular body may be adjusted as desired. For example,if it is desirable to produce a sheath that is expandable during use, anelastomeric material can be selected along with another material havinglower elastic properties. Forming a sheath using these materials,particularly in the tubular body, provides the sheath with the abilityto expand when subject to an applied force. As discussed herein, theconfiguration of the two or more materials in the sheath can vary andmay depend on use. For example, one of the materials may be selected tostiffen the overall tubular body, prevent kinking in the tubular body,and the like while the other material is selected based on an elasticproperty. The bond between the first and second materials can beadjusted to facilitate expansion of the sheath at an appropriate time orfor other reasons.

In addition, the use of a geometric pattern can also be combined withthe expandability of the sheath. The geometric pattern formed on theinner wall may be used to assist in splitting the sheath during use atan appropriate time, such as when the diameter exceeds a predeterminedlimit during expansion of the tubular member.

As described above, two or more materials may be utilized to form thesheath in accordance with the present invention. For example, adifferent material may be utilized to form the hub portion and one ormore materials may be utilized to form the tubular body of the sheath.Again, the selection of materials may depend on the end use of thesheath, properties of medical devices used with the sheath, and the likeor any combination thereof. Although the present invention has beenshown and described in accordance with specific embodiments these shouldnot be considered limiting in any manner. For example, multiplematerials may be utilized to form a unitary sheath in accordance withthe present invention, wherein multiple injection molding processes areperformed simultaneously or in stages to form the unitary sheath inaccordance with the present invention.

Embodiments of the introducer sheath described herein can be used invarious medical procedures. In one example, a medical procedure oftenbegins by introducing a sheath into body lumen, such as a patient'svasculature. After the sheath is properly introduced, a first medicaldevice can be introduced through the sheath. During introduction of thefirst medical device, the sheath or at least the tubular body of thesheath may expand to accommodate a size of the first medical device.

After the first medical device has been introduced, the medicalprocedure may be performed. During this procedure, in one example, thesize of the first medical device may change. During withdrawal of thefirst medical device, at least the tubular body of the sheath can expandor deform to accommodate the increased size of the first medical device.The expansion or change in cross-sectional area can occur at differentlocations of the sheath or the tubular body as the first medical deviceis withdrawn.

After the first medical device is withdrawn, a second medical device,such as a vessel closure device, stent delivery device, and/or othermedical device, can be introduced through the sheath. This newlyinserted medical device can be used without prior insertion of anotherintroducer sheath. In the case of the vessel closure device, the vesselclosure device can be placed in the desired location relative to thevessel wall and the introducer sheath removed before, during, or part ofthe vessel sealing process.

The above-described process is illustrated in more detail with referenceto FIGS. 22A-22D. FIGS. 22A-22D illustrate an example of oneconfiguration of an expandable introducer sheath during use in a medicalprocedure. A sheath 2600, which can be any of the introducer sheathspreviously described with respect to FIGS. 17-21, can be inserted into avessel or vasculature 600 or other body lumen of a patient. In thisexample, the tubular body 2604 of the sheath 2600 is formed of a firstelastomeric material 2606 and a second material 2608. With theintroducer sheath 2600 in place, one or more medical devices orinstruments can be passed therethrough, such as through the lumens ofthe hub portion 2602 and the tubular body 2604, to gain access to thevasculature 600 and more particular to a treatment site.

In one configuration, and with reference to FIG. 22B, a medical device,such as, but not limited to, a dilation balloon or an intra-aorticballoon pump, identified by reference numeral 2620, can be passedthrough the hub portion 2602. During use of the medical device 2620, theoutside diameter of the medical device 2620 increases in size from whenit was originally introduced into the vasculature 600 by way of thesheath 2600. The structure and function of the tubular body 2604 and/orthe introducer sheath 2600 can, however, accommodate such a change andeliminates the need to remove the introducer sheath 2600 with themedical device 2620.

With continued reference to FIG. 22B, once the medical procedure iscomplete, the medical device 2620 can be withdrawn until the medicaldevice 2620 contacts the distal end of the introducer sheath 2600 and/orthe entry portion 2628 that facilitates entry of the medical device 2620back through the sheath 2616. As the medical device 2620 is withdrawn,its size introduces a force that causes the tubular body 2604 to expandas the first elastomeric material 2606 flexes, expands, or deformsaccommodate the pump 2604, as illustrated in FIG. 22C.

As the medical device 2620 is withdrawn through the tubular body 2604,regions of the first elastomeric material 2606 expand, such as in region2612, such that a cross-sectional area of the lumen of the sheath 2600may increase, for example at least at this location. The medical device2620 can therefore be withdrawn without splitting the sheath 2600 orwithout having to remove the sheath 2600 from the vasculature 600 duringremoval of the medical device 2620.

After the medical device 2620 is withdrawn, FIG. 22D illustrates thatanother medical device 422, such as a vessel closure device, a stentdelivery device, or other medical device, can be introduced into thevasculature 600 via the sheath 2600. Without the expansion capabilityenabled by the embodiments disclosed herein, the sheath may need to beremoved earlier than desired, which could preclude use of other medicaldevices, such as, but not limited to, the vessel closure device.

FIGS. 23-26 illustrate cross-sections of various embodiments of atubular body of an alternative introducer sheath. Referring to theembodiment of FIG. 23, the tubular body 2700 may include a lumen 2712.The lumen 2712 may be defined by a wall 2710 similar to the lumen 2112in the embodiment of FIG. 17. The lumen 2712 may be defined at leastpartially by the wall 2710. For example, the lumen 2712 may be definedpartially by the wall 2710 and partially by at least one deformableexpandable portion 2780. In other embodiments, the lumen 2712 may beentirely defined by the wall 2710. The wall 2710 may include twodeformable expandable portions 2780 a, 2780 b.

The tubular body 2700 may include a secondary channel 2770. Thesecondary channel 2770 may be disposed within the wall 2710. Forexample, the secondary channel 2770 may be at least partially defined bythe wall 2710. The secondary channel 2770 may be defined partially bythe wall 2710 and partially by at least one of the deformable expandableportions 2780 a, 2780 b. In other embodiments, the secondary channel2770 may be entirely defined by the wall 2710.

The secondary channel 2770 may be configured to receive a guidewire (notshown) in a manner similar to that described above. For example, thesecondary channel 2770 may include at least one measurement ordimension, i.e. a diameter, width, etc., that is of sufficient size toreceive a guidewire. In embodiments where a guidewire is, for example, acylindrical guidewire with a diameter of about 1 mm, the secondarychannel 2770 may have a diameter of more than about 1 mm (for acylindrical channel) or a height and width of more than about 1 mm (fora rectangular channel). Furthermore, the secondary channel 2770 may haveother measurements or dimensions to accommodate various shapes (forexample, oval, polygonal, and/or other shapes) and sizes of guidewires.

The deformable expandable portions 2780 may be configured to increase across-sectional area of the tubular body 2700. It may be desirable toincrease a cross-sectional area of the tubular body 2700 to facilitatethe insertion and/or removal of apparatuses, i.e. medical devices orother apparatuses, into and/or from the tubular body 2700. Increasing across-sectional area of the tubular body 2700 may include increasing thecross-sectional area of the lumen 2712 and/or the cross-sectional areaof the secondary channel 2770. In some embodiments, the deformableexpandable portions 2780 may include an elastic portion as described inconnection with FIGS. 18-20. In other embodiments, the deformableexpandable portions 2780 may include a sheath portion as described inconnection with FIGS. 18-20. In further embodiments, the deformableexpandable portions 2780 may include expandable lumens 2720 in thetubular body 2700 as described in connection with FIG. 21.

In some embodiments, increasing the cross-sectional area of the tubularbody 2700 may include breaching the wall 2710 of the tubular body 2700such that the cross-sectional area is theoretically unbounded (thoughlikely bounded by the surrounding tissue of the body lumen). In theseembodiments, the deformable expandable portions 2780 may includeportions of weakened structural integrity. These portions of weakenedstructural integrity may facilitate breaching the wall 2710 by splittingthe tubular body 2700.

The deformable expandable portions 2780 may be positioned anywhere alongthe wall 2710 of the tubular body 2700. The locations of the deformableexpandable portions 2780 may be selected depending on the application ofthe sheath. For example, if it is desirable that the outer surface ofthe tubular body 2700 remain intact (i.e. not split), one deformableexpandable portion 2780 (i.e. the second deformable expandable portion2780 b) may be used between the lumen 2712 and secondary channel 2770,such that when an apparatus of larger size than the lumen 2712 or aguidewire of larger size than the secondary channel 2770 is used, thedeformable expandable portion 2780 may expand and/or split so that thelumen 2712 and secondary channel 2770 are no longer separated, therebyincreasing the cross-sectional area of both the lumen 2712 and thesecondary channel 2770.

In the present embodiment, the deformable expandable portions 2780 maybe configured to increase a cross-sectional area of the tubular body2700 by having a smaller thickness t₂ than the thickness (for examplet₁) of the rest of the wall 2710. The thickness of the deformableexpandable portions 2780 may be uniform or non-uniform. The thickness ofthe wall 2710 may be uniform or non-uniform.

The first deformable expandable portion 2780 a may increase across-sectional area of the tubular body 2700 by increasing across-sectional area of the lumen 2712. For example, if the firstdeformable expandable portion 2780 a were the only deformable expandableportion 2780 in the tubular body 2700 of FIG. 23, when an apparatus oflarger diameter than the lumen 2712 is inserted into the lumen, thefirst deformable expandable portion 2780 a may expand. If the firstdeformable expandable portion 2780 a expands up to a predetermineddiameter and/or by a predetermined amount, the first deformableexpandable portion 2780 a may only expand a certain distance therebyincreasing the cross-sectional area of the lumen 2712. If the firstdeformable expandable portion 2780 a expands to and/or beyond apredetermined diameter and/or by a predetermined amount, the firstdeformable expandable portion 2780 a may split thereby increasing thecross-sectional area of the lumen 2712.

The second deformable expandable portion 2780 b may increase across-sectional area of the tubular body 2700 by increasing across-sectional area of the lumen 2712 and/or secondary channel 2770.For example, if the second deformable expandable portion 2780 were theonly deformable expandable portion 2780 in the tubular body 2700 of FIG.23, when an apparatus and/or a guidewire of larger diameter than thelumen 2712 and/or secondary channel 2770 is inserted into the lumen 2712and/or secondary channel 2770, the second deformable expandable portion2780 b may expand. If the second deformable expandable portion 2780expands up to a predetermined diameter and/or by a predetermined amount,the second deformable expandable portion 2780 may only expand a certaindistance thereby increasing the cross-sectional area of the lumen 2712and/or secondary channel 2770. If the second deformable expandableportion 2780 expands to and/or beyond a predetermined diameter and/or bya predetermined amount, the second deformable expandable portion 2780may split thereby increasing the cross-sectional area of the lumen 2712and/or secondary channel 2770 (by joining the lumen 2712 and secondarychannel 2770).

The tubular body 2700 may be formed using one or more materials asdescribed above. The deformable expandable portions 2780 may include thesame material as the remainder of the wall 2710, as in the presentembodiment. In other embodiments, at least one deformable expandableportion 2780 may include different materials.

FIGS. 24-26 illustrate cross-sections of various embodiments of atubular body of an introducer sheath, in accordance with the presentinvention. The introducer sheaths of these alternative embodiments maybe functionally similar to that of the device previously described aboveand shown in FIG. 23 in most respects, wherein certain features will notbe described in relation to the alternative embodiments wherein thosecomponents may function in the manner as described above and are herebyincorporated into the alternative embodiments described below.

Referring to the embodiment of FIG. 24, the tubular body 2800 mayinclude two deformable expandable portions 2880 a, 2880 b. In thepresent embodiment, the deformable expandable portions 2880 may beconfigured to increase a cross-sectional area of the tubular body 2800by having overlapping portions 2890. In the present embodiment, thetubular body 2800 includes two deformable expandable portions 2880 a,2880 b in the form of two pairs of overlapping portions 2890 a, 2890 b.

The first overlapping portions 2890 a may increase a cross-sectionalarea of the tubular body 2800 by increasing a cross-sectional area ofthe lumen 2812. For example, if the first overlapping portions 2890 awere the only deformable expandable portion 2880 in the tubular body2800 of FIG. 24, when an apparatus of larger diameter than the lumen2812 is inserted into the lumen 2812, the first overlapping portions2890 a may expand. If the first overlapping portions 2890 a expands upto a predetermined diameter and/or by a predetermined amount, the firstoverlapping portions 2890 a may only expand a certain distance (i.e. thetwo arms of the first overlapping portions 2890 a may begin to separatewhile still overlapping) thereby increasing the cross-sectional area ofthe lumen 2812. If the first overlapping portions 2890 a expand toand/or beyond a predetermined diameter and/or by a predetermined amount,the first overlapping portions 2890 may split (i.e. the two arms mayopen to allow the medical device to exit the lumen 2812) therebyincreasing the cross-sectional area of the lumen 2812.

The second overlapping portions 2890 b may increase a cross-sectionalarea of the tubular body 2800 by increasing a cross-sectional area ofthe secondary channel 2870 in a manner similar to the first overlappingportions 2890 a. For example, if the second overlapping portions 2890 bwere the only deformable expandable portion 2880 in the tubular body2800, when a guidewire of larger diameter than the secondary channel2870 is inserted into the secondary channel 2870, the second overlappingportions 2890 b may expand. If the second overlapping portions 2890expand up to a predetermined diameter and/or by a predetermined amount,the second overlapping portions 2890 may only expand a certain distance(i.e. the two arms of the second overlapping portions 2890 b may beginto separate while still overlapping) thereby increasing thecross-sectional area of the secondary channel 2870. If the secondoverlapping portions 2890 expands to and/or beyond a predetermineddiameter and/or by a predetermined amount, the second overlappingportions 2890 may split (i.e. the two arms may open to allow theguidewire to exit the secondary channel 2870) thereby increasing thecross-sectional area of the secondary channel 2870.

Referring to the embodiment of FIG. 25, the tubular body 2900 mayinclude six deformable expandable portions 2980. The deformableexpandable portions 2980 may be configured to increase a cross-sectionalarea of the tubular body 2900 by including geometric patterns 2932 thatare similar to the geometric patterns 2232 described in connection withFIG. 19. Additional examples of geometric patterns 2232 are illustratedin FIGS. 25A and 25B.

In the present embodiment, the geometric patterns 2932 may be configuredto facilitate splitting of at least a portion of the tubular body 2900.For example, the geometric patterns 2932 may be configured to facilitatesplitting the tubular body 2900 near the secondary channel 2970 and/orlumen 2912.

The geometric patterns 2932, in the present embodiment, may be locatedon both sides of the wall 2910 of the tubular body 2900. For example,the first and second geometric patterns 2932 a, 2932 b, in the presentembodiment, are located on both sides of the wall 2910 at a locationnear the lumen 2912 farthest from the secondary channel 2970. In otherembodiments, only one geometric pattern 2932 may be positioned at thislocation. For example, only the first geometric pattern 2932 a locatedon an outside surface of the wall 2910 farthest from the secondarychannel 2970 may be used. Alternatively, only the second geometricpattern 2932 b located on an inside surface of the wall 2910 farthestfrom the secondary channel 2970 may be used.

Referring to the geometric patterns (not shown) illustrated in FIGS. 25Aand 25B, FIG. 25A includes longitudinal grooves 2934 as geometricpatterns. The longitudinal grooves 2934 may be formed as deformableexpandable portions. For example, the tubular body 2700′ may be extrudedwith the longitudinal grooves 2934. In another example, the longitudinalgrooves 2934 may be a separation line, such as a line that is pre-scoredin the deformable expandable portions. In the present embodiment,multiple longitudinal grooves 2934 may be included. In otherembodiments, a single longitudinal groove 2934 may be included.

FIG. 25B illustrates another embodiment of a geometric pattern. Thegeometric pattern shown in FIG. 25B may be a longitudinal groove 2934′.The longitudinal groove 2934′, in the present embodiment, may be aspiral shaped longitudinal groove 2934′. In other embodiments, aplurality of longitudinal grooves 2934′ may be used. In furtherembodiments, a plurality of longitudinal grooves 2934′ may be used.

Referring to the embodiment of FIG. 26, the tubular body 3000 mayinclude three deformable expandable portions 3080. The deformableexpandable portions 3080 may be configured to increase a cross-sectionalarea of the tubular body 3000 by being formed of a weaker material thanthe other portions of the tubular body 3000.

Similar to the first deformable expandable portion 2780 a described inconnection with FIG. 23, the first deformable expandable portion 3080 a,in the present embodiment, may increase a cross-sectional area of thetubular body 3000 by increasing a cross-sectional area of the lumen3012. However, rather than having a smaller thickness compared to otherportions of the tubular body 3000, the deformable expandable portions3080 of the present embodiment may have the same and/or greaterthickness compared to other portions of the tubular body 3000. Across-sectional area of the tubular body 3000 may still be increasedbecause the deformable expandable portions 3080 may include materialthat is of weakened structural integrity than the remaining portions ofthe tubular body 3000. The weaker material may facilitate expansionand/or splitting of the deformable expandable portions 3080 when thedeformable expandable portions 3080 expand up to and/or beyond apredetermined diameter and/or by a predetermined amount therebyincreasing the cross-sectional area of the tubular body 3000.

In some embodiments, the deformable expandable portions 3080 may becoextruded with the rest of the tubular body 3000. In other embodiments,the deformable expandable portions 3080 may be bonded to the rest of thetubular body 3000 through, for example, a friction fit, mechanicalbonding, adhesives, thermal or chemical bonding, combinations thereof orother bonding methods.

FIGS. 27A-29B illustrate cross-sections of further embodiments of atubular body of an introducer sheath, in accordance with the presentdisclosure. The introducer sheaths of these further embodiments may befunctionally similar to that of the device previously described aboveand shown in FIGS. 23-26 in most respects, wherein certain features willnot be described in relation to the alternative embodiments whereinthose components may function in the manner as described above and arehereby incorporated into the alternative embodiments described below.

Referring to the embodiment shown in FIGS. 27A-27E, the tubular body3100 may include a lumen 3112. The lumen 3112 may be defined by a wall3110 similar to the lumen 2112, 2712 in the embodiments of FIGS. 17 and23, respectively. The lumen 3112 may be defined at least partially bythe wall 3110. For example, the lumen 3112 may be defined partially bythe wall 3110 and partially by at least one expandable divider, such asexpandable divider 3180 b. In other embodiments, the lumen 3112 may beentirely defined by the wall 3110.

The tubular body 3100 may include a channel 3170. The channel 3170 maybe disposed within the wall 3110. For example, the channel 3170 may beat least partially defined by the wall 3110. The channel 3170 may bedefined partially by the wall 3110 and partially by the expandabledivider 3180 b. In other embodiments, the channel 3170 may be entirelydefined by the wall 3110.

The channel 3170 may be configured to receive a guidewire (not shown) ina manner similar to that described above. For example, the channel 3170may include at least one measurement or dimension, i.e. a diameter,width, area, other dimension, or combinations thereof, that is ofsufficient size to receive a guidewire. In embodiments where a guidewireis, for example, a cylindrical guidewire with a diameter of about 1 mm,the channel 3170 may have a diameter of more than about 1 mm (for acylindrical channel) or a height and width of more than about 1 mm (fora rectangular channel). Furthermore, the channel 3170 may have othermeasurements or dimensions to accommodate various shapes (for example,oval, polygonal, other shapes, or combinations thereof) and/or sizes ofguidewires.

The expandable divider 3180 b may be configured to increase across-sectional area of the lumen 3112 from a pre-expanded configurationtoward an expanded configuration. FIG. 27A illustrates the expandabledivider 3180 b in the pre-expanded configuration; FIG. 27B illustratesthe expandable divider 3180 b in the expanded configuration; FIG. 27Cillustrates the expandable divider 3180 c in an elastically deformedconfiguration; FIG. 27D illustrates the expandable divider 3180 c in aplastically deformed configuration; and FIG. 27E illustrates theexpandable divider 3180 c in the pre-expanded configuration after beingtransitioned to the plastically deformed configuration shown in FIG.27D. It may be desirable to increase a cross-sectional area of the lumen3112 to facilitate the insertion and/or removal of apparatuses, i.e.medical devices or other apparatuses, into and/or from the lumen 3112.The expandable divider 3180 b may be configured to increase across-sectional area of the channel 3170.

In the present configuration, the expandable divider 3180 b may includea first end 3181 a and a second end 3181 b. The expandable divider 3180b, as shown in FIG. 27A, may have a generally sinusoidal shape from thefirst end 3181 a toward the second end 3181 b. In other embodiments, theexpandable divider 3180 b may have a sinusoidal shape, a concertinashape, an overlapping shape, a serpentine shape, other shapes, orcombinations thereof.

A first linear length 3183 may be defined from the first end 3181 atoward the second end 3181 b. A linear length may include the shortestdistance between two points, for example the shortest distance betweenthe first end 3181 a and the second end 3181 b.

If the expandable divider 3180 b expands up to a predetermined dimensionand/or by a predetermined amount, the expandable divider 3180 b may onlyexpand a certain distance thereby increasing the cross-sectional area ofthe lumen 3112 and/or channel 3170. The expandable divider 3180 b maytransition beyond a predetermined dimension and/or a predeterminedamount. For instance, the expandable divider 3180 b may elasticallyand/or plastically deform when an instrument and/or guidewire expandsthe expandable divider beyond its unfurled or expanded size.

The predetermined dimension may include a first divider length, shown as3182 a, 3182 b, 3182 c, 3182 d, 3182 e in FIGS. 27A-27E, respectively.The first divider length 3182 a, 3182 b, 3182 c, 3182 d, 3182 e may bedefined from the first end 3181 a toward the second end 3181 b along theexpandable divider 3180 b. A divider length may include the distancealong a divider between two points, for example the distance along theexpandable divider 3180 b between the first end 3181 a and the secondend 3181 b. A divider length may include the distance along a length ofa curved, stepped, concertina shape, and/or other divider.

The first divider length 3182 a, shown in FIG. 27A, may be about thesame as the first divider length 3182 b, shown in FIG. 27B. The firstdivider length 3182 c in the elastically deformed configuration may belonger than the first divider length 3182 a in the pre-expandedconfiguration and/or the first divider length 3182 b in the expandedconfiguration. The first divider length 3182 d in the plasticallydeformed configuration is generally longer than the first divider length3182 a in the pre-expanded configuration, the first divider length 3182b in the expanded configuration, the first divider length 3182 c in theelastically deformed configuration, or combinations thereof. The firstdivider length 3182 e in the pre-expanded configuration after beingtransitioned to the plastically deformed configuration shown in FIG. 27Dmay be longer than the first divider length 3182 a in the pre-expandedconfiguration, the first divider length 3182 b in the expandedconfiguration, the first divider length 3182 c in the elasticallydeformed configuration, or combinations thereof.

The first linear length 3183 may be related to the first divider length3182 a, 3182 b, 3182 c, 3182 d, 3182 e. For instance, the first linearlength 3183 may be a chord length with respect to the first dividerlength 3182 b, 3182 c, 3182 d, when in the expanded, elasticallydeformed, or plastically deformed configurations. In another example,the first linear length 3183 may be directly proportional to the firstdivider length 3182 a, 3182 b, 3182 c, 3182 d, 3182 e. In the presentconfiguration, the first divider length 3182 a, 3182 b in thepre-expanded and expanded configurations may be about fifty percentlonger than the first linear length 3183. For example, an innerdimension 3184 a of the lumen 3112 in the pre-expanded configuration maybe about eight French compared to a ten French inner dimension 3184 b inthe expanded configuration.

In other embodiments, the first divider length 3182 a, 3182 b, 3182 c,3182 d, 3182 e may be more or less than about fifty percent longer thanthe first linear length 3183. For instance, the first divider length3182 a, 3182 b, 3182 c, 3182 d, 3182 e may be between about five percentand about ninety-five percent, twenty percent and about eighty percent,forty percent and about seventy percent, or other ranges longer than thefirst linear length 3183. In another example, the ratio of an innerdimension 3184 a of the lumen 3112 in the pre-expanded configuration toan inner dimension 3184 b in the expanded configuration may be about sixFrench compared to about twelve French, about seven French to abouttwelve French, about eight French to about twelve French, about eightFrench to about eleven French, about eight French to about ten French,about eight French to about nine French, or other ratios.

The inner dimension 3184 a in the pre-expanded configuration shown inFIG. 27A is generally smaller than the inner dimension 3184 b in theexpanded state shown in FIG. 27B. The inner dimension 3184 c in theelastically deformed configuration may be larger than the innerdimension 3184 a in the pre-expanded configuration and/or the innerdimension 3184 b in the expanded configuration. The inner dimension 3184d in the plastically deformed configuration is generally larger than theinner dimension 3184 a in the pre-expanded configuration, the innerdimension 3184 b in the expanded configuration, the inner dimension 3184c in the elastically deformed configuration, or combinations thereof.The inner dimension 3184 e in the pre-expanded configuration after beingtransitioned to the plastically deformed configuration shown in FIG. 27Dmay be larger than the inner dimension 3184 a in the pre-expandedconfiguration, the inner dimension 3184 b in the expanded configuration,the inner dimension 3184 c in the elastically deformed configuration, orcombinations thereof.

In some embodiments, increasing the cross-sectional area of the tubularbody 3100 may include breaching the wall 3110 of the tubular body 3100such that the cross-sectional area is theoretically unbounded (thoughlikely bounded by the surrounding tissue of the body lumen). In theseembodiments, the deformable expandable dividers 3180 may includeportions of weakened structural integrity. These portions of weakenedstructural integrity may facilitate breaching the wall 3110 by splittingthe tubular body 3100. As shown in FIGS. 27A-27B, the expandable divider3180 b is not configured to be breached, but rather is configured tounfurl or expand toward the expanded configuration, as shown in FIG.27B.

The expandable divider 3180 b may be positioned between the lumen 3112and channel 3170, such that when an apparatus of larger size than thelumen 3112 or a guidewire of larger size than the channel 3170 is used,the expandable divider 3180 b may unfurl or expand to accommodate anapparatus of larger size than the lumen 3112 and/or may split so thatthe lumen 3112 and channel 3170 are no longer separated, therebyincreasing the cross-sectional area of both the lumen 3112 and thechannel 3170.

The expandable divider 3180 b may increase a cross-sectional area of thelumen 3112 and/or channel 3170. For example, if the expandable divider3180 b were the only expandable divider in the tubular body 3100 of FIG.27, when an apparatus and/or a guidewire of larger diameter than thelumen 3112 and/or channel 3170 is inserted into the lumen 3112 and/orchannel 3170, the expandable divider 3180 b may expand (i.e. withoutdeforming, elastically deforming, plastically deforming, or combinationsthereof) from the lumen 3112 toward the channel 3170 or vice versa. Forinstance, FIG. 27B illustrates (in phantom) the expansion of theexpandable divider 3180 b into the lumen 3112.

The tubular body 3100 may be formed using one or more materials asdescribed above. The expandable divider 3180 b may include the samematerial as the remainder of the wall 3110, as in the presentembodiment. In other embodiments, the expandable divider 3180 b mayinclude different materials. The expandable divider 3180 b and/or wall3110 may be extruded or otherwise formed in their unexpanded shape, asshown in FIG. 27A. In embodiments where the expandable divider 3180 bmay be elastically deformable, the expandable divider 3180 b may returnto its original shape after a medical instrument and/or guidewire isremoved from the lumen 3112 and/or channel 3170.

Referring to the embodiment shown in FIGS. 28A-28B, the tubular body3200 may include a lumen 3212. The lumen 3212 may be defined by a wall3210 similar to the lumen 2112, 2712 in the embodiments of FIGS. 17 and23, respectively. The lumen 3212 may be defined at least partially bythe wall 3210. For example, the lumen 3212 may be defined partially bythe wall 3210 and partially by at least one expandable divider, such asexpandable divider 3280 b. In other embodiments, the lumen 3212 may beentirely defined by the wall 3210.

The tubular body 3200 may include a channel 3270. The channel 3270 maybe disposed within the wall 3210. For example, the channel 3270 may beat least partially defined by the wall 3210. The channel 3270 may bedefined partially by the wall 3210 and partially by the expandabledivider 3280 b. In other embodiments, the channel 3270 may be entirelydefined by the wall 3210. The channel 3270 may be configured to receivea guidewire (not shown) in a manner similar to that described above.

The expandable divider 3280 b may be configured to increase across-sectional area of the lumen 3212 from a pre-expanded configurationtoward an expanded configuration. FIG. 28A illustrates the expandabledivider 3280 b in the pre-expanded configuration while FIG. 28Billustrates the expandable divider 3280 b in the expanded configuration.The expandable divider 3280 b may be configured to increase across-sectional area of the channel 3270.

In the present configuration, the expandable divider 3280 b may includea first end 3281 a and a second end 3281 b. The expandable divider 3280b, as shown in FIG. 28A, may have a generally concertina shape from thefirst end 3281 a toward the second end 3281 b. In other embodiments, theexpandable divider 3280 b may have a sinusoidal shape, a concertinashape, an overlapping shape, a serpentine shape, other shapes, orcombinations thereof.

A first linear length 3283 a may be defined from the first end 3281 atoward the second end 3281 b along the expandable divider 3280 b. Afirst curve length 3282 a may be defined from the first end 3281 atoward the second end 3281 b. The first linear length 3283 a may berelated to the first curve length 3282 a. In the present configuration,the first curve length 3282 a may be about fifty percent longer than thefirst linear length 3283 a. In other embodiments, the first dividerlength 3282 a may be more or less than about fifty percent longer thanthe first linear length 3283 a. For instance, the first divider length3282 a may be between about five percent and about ninety-five percent,twenty percent and about eighty percent, forty percent and about seventypercent, or other ranges longer than the first linear length 3283 a. Inanother example, an inner dimension 3284 a of the lumen 3112 in thepre-expanded configuration may be about eight French compared to a tenFrench inner dimension 3284 b in the expanded configuration.

In some embodiments, increasing the cross-sectional area of the tubularbody 3200 may include breaching the wall 3210 of the tubular body 3200such that the cross-sectional area is theoretically unbounded (thoughlikely bounded by the surrounding tissue of the body lumen). In theseembodiments, the deformable expandable dividers 3280 may includeportions of weakened structural integrity. These portions of weakenedstructural integrity may facilitate breaching the wall 3210 by splittingthe tubular body 3200. As shown in FIGS. 28A-28B, the expandable divider3280 b is not configured to be breached, but rather is configured tounfurl or expand toward the expanded configuration, as shown in FIG.28B.

The expandable divider 3280 b may be positioned between the lumen 3212and channel 3270, such that when an apparatus of larger size than thelumen 3212 or a guidewire of larger size than the channel 3270 is used,the expandable divider 3280 b may unfurl or expand to accommodate anapparatus of larger size than the lumen 3212 and/or may split so thatthe lumen 3212 and channel 3270 are no longer separated, therebyincreasing the cross-sectional area of both the lumen 3212 and thechannel 3270.

The expandable divider 3280 b may increase a cross-sectional area of thelumen 3212 and/or channel 3270. If the expandable divider 3280 b expandsup to a predetermined diameter and/or by a predetermined amount, theexpandable divider 3280 b may only expand a certain distance therebyincreasing the cross-sectional area of the lumen 3212 and/or channel3270. The expandable divider 3280 b may deform beyond its expanded orunfurled capacity. For instance, the expandable divider 3280 b mayelastically and/or plastically deform when an instrument and/orguidewire expands the expandable divider beyond its unfurled or expandedsize.

The predetermined dimension may include a first divider length, shown as3282 a, 3282 b in FIGS. 28A-28B, respectively. The first divider length3282 a, 3282 b may be defined from the first end 3281 a toward thesecond end 3281 b along the expandable divider 3280 b. A divider lengthmay include the distance along a divider between two points, for examplethe distance along the expandable divider 3280 b between the first end3281 a and the second end 3281 b. A divider length may include thedistance along a length of a curved, stepped, concertina shape, and/orother divider.

The first divider length 3282 a, shown in FIG. 28A, may be about thesame as the first divider length 3282 b, shown in FIG. 28B. Theexpandable divider 3280 b may transition to an elastically deformedconfiguration (similar to the elastically deformed configuration shownin FIG. 27C), to a plastically deformed configuration (similar to theplastically deformed configuration shown in FIG. 27D), to a pre-expandedconfiguration after being transitioned to the plastically deformedconfiguration (similar to the pre-expanded configuration after beingtransitioned to the plastically deformed configuration shown in FIG.27D).

The tubular body 3200 may be formed using one or more materials asdescribed above. The expandable divider 3280 b may include the samematerial as the remainder of the wall 3210, as in the presentembodiment. In other embodiments, the expandable divider 3280 b mayinclude different materials. The expandable divider 3280 b and/or wall3210 may be extruded or otherwise formed in their unexpanded shape, asshown in FIG. 28A. In embodiments where the expandable divider 3280 bmay be elastically deformable, the expandable divider 3280 b may returnto its original shape after a medical instrument and/or guidewire isremoved from the lumen 3212 and/or channel 3270.

Referring to the embodiment shown in FIGS. 29A-29B, the tubular body3300 may include a lumen 3312. The lumen 3312 may be defined by a wall3310 similar to the lumen 2112, 2712 in the embodiments of FIGS. 17 and23, respectively. The lumen 3312 may be defined at least partially bythe wall 3310. For example, the lumen 3312 may be defined partially bythe wall 3310 and partially by at least one expandable divider, such asexpandable divider 3380 b. In other embodiments, the lumen 3312 may beentirely defined by the wall 3310.

The tubular body 3300 may include a channel 3370. The channel 3370 maybe disposed within the wall 3310. For example, the channel 3370 may beat least partially defined by the wall 3310. The channel 3370 may bedefined partially by the wall 3310 and partially by the expandabledivider 3380 b. In other embodiments, the channel 3370 may be entirelydefined by the wall 3310. The channel 3370 may be configured to receivea guidewire (not shown) in a manner similar to that described above.

The expandable divider 3380 b may be configured to increase across-sectional area of the lumen 3312 from a pre-expanded configurationtoward an expanded configuration. FIG. 29A illustrates the expandabledivider 3380 b in the pre-expanded configuration while FIG. 29Billustrates the expandable divider 3380 b in the expanded configuration.The expandable divider 3380 b may be configured to increase across-sectional area of the channel 3370.

In the present configuration, the expandable divider 3380 b may includea first end 3381 a and a second end 3381 b. The expandable divider 3380b, as shown in FIG. 29A, may have a generally overlapping shape from thefirst end 3381 a toward the second end 3381 b. In other embodiments, theexpandable divider 3380 b may have a sinusoidal shape, a concertinashape, an overlapping shape, a serpentine shape, other shapes, orcombinations thereof.

A first linear length 3382 a may be defined from the first end 3381 atoward the second end 3381 b along the expandable divider 3380 b. Afirst curve length 3382 b may be defined from the first end 3381 atoward the second end 3381 b. The first linear length 3382 a may berelated to the first curve length 3382 b. In the present configuration,the first curve length 3382 b may be about fifty percent longer than thefirst linear length 3382 a. In other embodiments, the first dividerlength 3382 b may be more or less than about fifty percent longer thanthe first linear length 3382 a. For instance, the first divider length3382 b may be between about five percent and about ninety-five percent,twenty percent and about eighty percent, forty percent and about seventypercent, or other ranges longer than the first linear length 3382 a.

In some embodiments, increasing the cross-sectional area of the tubularbody 3300 may include breaching the wall 3310 of the tubular body 3300such that the cross-sectional area is theoretically unbounded (thoughlikely bounded by the surrounding tissue of the body lumen). In theseembodiments, the deformable expandable dividers 3380 may includeportions of weakened structural integrity. These portions of weakenedstructural integrity may facilitate breaching the wall 3310 by splittingthe tubular body 3300. As shown in FIGS. 29A-29B, the expandable divider3380 b is not configured to be breached, but rather is configured tounfurl or expand toward the expanded configuration, as shown in FIG.29B.

The expandable divider 3380 b may be positioned between the lumen 3312and channel 3370, such that when an apparatus of larger size than thelumen 3312 or a guidewire of larger size than the channel 3370 is used,the expandable divider 3380 b may unfurl or expand to accommodate anapparatus of larger size than the lumen 3312 and/or may split so thatthe lumen 3312 and channel 3370 are no longer separated, therebyincreasing the cross-sectional area of both the lumen 3312 and thechannel 3370.

The expandable divider 3380 b may increase a cross-sectional area of thelumen 3312 and/or channel 3370. If the expandable divider 3380 b expandsup to a predetermined diameter and/or by a predetermined amount, theexpandable divider 3380 b may only expand a certain distance therebyincreasing the cross-sectional area of the lumen 3312 and/or channel3370. The expandable divider 3380 b may deform beyond its expanded orunfurled capacity. For instance, the expandable divider 3380 b mayelastically and/or plastically deform when an instrument and/orguidewire expands the expandable divider beyond its unfurled or expandedsize.

The predetermined dimension may include a first divider length, shown as3382 a, 3382 b in FIGS. 29A-29B, respectively. The first divider length3382 a, 3382 b may be defined from the first end 3381 a toward thesecond end 3381 b along the expandable divider 3380 b. A divider lengthmay include the distance along a divider between two points, for examplethe distance along the expandable divider 3380 b between the first end3381 a and the second end 3381 b. A divider length may include thedistance along a length of a curved, stepped, concertina shape, and/orother divider.

The first divider length 3382 a, shown in FIG. 29A, may be about thesame as the first divider length 3382 b, shown in FIG. 29B. Theexpandable divider 3380 b may transition to an elastically deformedconfiguration (similar to the elastically deformed configuration shownin FIG. 27C), to a plastically deformed configuration (similar to theplastically deformed configuration shown in FIG. 27D), to a pre-expandedconfiguration after being transitioned to the plastically deformedconfiguration (similar to the pre-expanded configuration after beingtransitioned to the plastically deformed configuration shown in FIG.27D).

The tubular body 3300 may be formed using one or more materials asdescribed above. The expandable divider 3380 b may include the samematerial as the remainder of the wall 3310, as in the presentembodiment. In other embodiments, the expandable divider 3380 b mayinclude different materials. The expandable divider 3380 b and/or wall3310 may be extruded or otherwise formed in their unexpanded shape, asshown in FIG. 29A. In embodiments where the expandable divider 3380 bmay be elastically deformable, the expandable divider 3380 b may returnto its original shape after a medical instrument and/or guidewire isremoved from the lumen 3312 and/or channel 3370.

FIG. 30 illustrates a perspective view of an embodiment of an introducersheath 3000. The introducer sheath 3400 of the embodiment describedherein and shown in FIG. 30 may be functionally similar to theintroducer sheaths described herein in most respects, wherein certainfeatures may not be described in relation to this embodiment whereinthose components may function in the manner as described above and arehereby incorporated into this embodiment described below. Likestructures and/or components are given like reference numerals.

The introducer sheath 3400 may include a hub portion 3402 with anelongate or tubular portion 3404 extending therefrom. As illustrated,the hub portion 3402 may include a strain relief portion 3408 to provideadditional support to a proximal end 3418 of the elongate portion 3404to prevent kinking at the transition between the proximal end 3418 ofthe elongated portion 3404 and a distal end 3414 of the hub portion3402. The hub portion 3402 may also include a valve member 3422, such asa hemostatis valve, and a fluid port 3424 configured to permit fluid(e.g., blood, antibiotics, plasma, saline, etc.) to be introduced and/orextracted through the hub portion 3402. The fluid port 3424 may beconfigured to align and/or selectively lock any device (e.g., a vesselclosure device, a catheter) used in conjunction with the sheath 3400.Other combinations of structures of the hub portion 3402 are possible.

The elongate portion 3404 may extend between the proximal end 3418 and adistal end 3420. The elongate portion 3404 may include an inner portion3403 and an outer portion 3405, with the inner portion 3403 and/or theouter portion 3405 extending between the proximal end 3418 and thedistal end 3420 of the tubular portion 3404.

As illustrated, the inner portion 3403 may form a lumen 3412. The lumen3412 may include an entry portion, such as entry portion 2228 shown inFIG. 18. The outer portion 3405 of the lumen 3412 may be disposedpartially around the inner portion 3403. For example, at least a portionof the inner portion 3403 may be exposed between the proximal end 3418and the distal end 3420 of the tubular portion 3404 by way of at leastone aperture 3440. In the present embodiment, the aperture 3440 mayextend from the proximal end 3418 toward the distal end 3420 andterminate at the distal end 3420. In other embodiments, the aperture3440 may extend from the proximal end 3418 and terminate proximal thedistal end 3420. In still another configuration, the aperture 3440 maybe disposed between and spaced apart from either or both the proximalend 3418 and the distal end 3420. The aperture 3440 may extend from anouter surface 3407 of the outer portion 3405 to an outer surface 3441 ofthe inner portion 3403. The aperture 3440 may vary in size. For example,the aperture 3440 as shown in FIG. 30 may define a gap. In otherembodiments, the aperture 3440 may be smaller, like a slit. Although,regardless of the size of the aperture 3440, as the sheath 3400 expands,the aperture 3440 will increase in size.

FIG. 31 illustrates a cross-sectional view of the elongate portion 3404of the introducer sheath 3400 of FIG. 30 along line 31-31 of FIG. 30 inan unexpanded state. The lumen 3512 of the introducer sheath 3500illustrated in FIG. 31 is in an unexpanded state. The lumen 3512 mayinclude a first inner dimension 3512 a. The first inner dimension 3512 amay include a diameter, a cross-sectional area, a radius, an arc length,other dimensions, or combinations thereof. For example, the first innerdimension 3512 a may be a diameter of about six French.

The inner portion 3503 may include a first material that may include atleast one relatively expandable material. The first material may providelubricious properties to facilitate medical devices being insertedand/or removed through the lumen 3512. For example, the first materialmay include ePTFE, which may provide both expandability and lubricity.

The outer portion 3505 may include a second material that may provideexpandability and/or lubricity. For example, the second material mayinclude an elastomeric material. In the present embodiment, the secondmaterial may be less expandable (i.e. may have a lower modulus ofelasticity) than the first material of the inner portion 3503. Inembodiments where the second material may be less expandable than thefirst material and despite the reduced expandability of the secondmaterial, the exposure of the inner portion 3503 through at least aportion of the outer portion 3505 may facilitate expansion of the innerportion 3503. A less expandable second material may increase thelongitudinal strength (i.e. resistance to buckling in the longitudinaldirection) and/or pushability of the introducer sheath while providingradial and/or other expandability of the introducer sheath through themore expandable first material.

The inner portion 3503 and/or the outer portion 3505 may be arranged tofacilitate entry and/or exit of a medical device through the lumen 3512by expanding to accommodate the medical device without creating furtherapertures (not shown) in the outer surface 3507 of the tubular portion3504.

FIG. 31 illustrates a cross-sectional view of the elongate or tubularportion 3504′ of the introducer sheath 3400 along line 31-31 of FIG. 30in an expanded state. The elongate portion 3504′ of the embodimentdescribed herein and shown in FIG. 9 may be functionally similar to theintroducer sheaths and/or tubular portions described herein in mostrespects, wherein certain features may not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this embodimentdescribed below. Like structures and/or components are given likereference numerals.

The elongate portion 3504′, the inner portion 703′, the outer portion3505′, the lumen 3512′, the aperture 3540′, other components of theintroducer sheath 3400, or combinations thereof, may increase in atleast one dimension in the expanded state. The inner portion 3503′ andthe outer portion 3505′ may expand in conjunction with the lumen 3512′.The aperture 3540′ may expand circumferentially. Expansion of theaperture 3540′ may increase the size of the exposed portion of the innerportion 3503′ of the elongate portion 3504′. The outer portion 3505′ maybe disposed around less of the inner portion 3503′ in the expandedstate.

The lumen 3512′ is shown in FIG. 32 in the expanded state. The lumen3512′ may include a second inner dimension 3512 a′. The second innerdimension 3512 a′ may include a diameter, a cross-sectional area, aradius, an arc length, other dimensions, or combinations thereof. Forexample, the second inner dimension 3512 a′ may be a diameter of aboutten French. The lumen 3512 (shown in FIG. 31) may expand from a firstinner dimension 3512 a to a second inner dimension 3512 a′ of the lumen3512′. This expansion may be about sixty-five percent. For example, fromabout six French to about ten French. In other embodiments, theexpansion may be more and/or less than about sixty-five percent. Forexample, it may be as little as about ten percent.

FIG. 33 illustrates a cross-sectional view of another embodiment of anelongate or tubular portion 3604 of an introducer sheath in anunexpanded state. The tubular portion 3604 of the embodiment describedherein and shown in FIG. 33 may be functionally similar to theintroducer sheaths and/or tubular portions described herein in mostrespects, wherein certain features may not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this embodimentdescribed below. Like structures and/or components are given likereference numerals. For example, the tubular portion 3604 may be usedwith the introducer sheath 3400 to include a hub portion 3402.

The tubular portion 3604 may extend between a proximal end (such asproximal end 3418 shown in FIG. 30) and a distal end (such as distal end3420 shown in FIG. 30). The tubular portion 3604 may include an innerportion 3603 and an outer portion 3605. The inner portion 3603 and/orthe outer portion 3605 may extend between the proximal end (such asproximal end 3418 shown in FIG. 30) and the distal end (such as distalend 3420 shown in FIG. 30) of the tubular portion 3604.

In the present embodiment, the inner portion 3603 may form at least twolumens 3612, 3613. The lumens 3612, 3613 may include an entry portion,such as entry portion 2228 shown in FIG. 18. The outer portion 3605 maybe disposed partially around the inner portion 3603. For example, atleast a portion of the inner portion 3603 may be exposed between theproximal end and the distal end of the tubular portion 3604. Inembodiments such as the present embodiment, multiple portions of theinner portion 3603 may be exposed.

The tubular portion 3604 may include at least one aperture 3640 a. Inthe presently illustrated embodiment, the tubular portion 3604 mayinclude a first aperture 3640 a, a second aperture 3640 b, and a thirdaperture 3640 c. The apertures 3640 a, 3640 b, 3640 c may expose atleast a portion of the inner portion 3603 between the proximal end(shown as 3418 in FIG. 30) and the distal end (shown as 3420 in FIG. 30)of the tubular portion 3604.

For example, the first aperture 3640 a may expose a portion of the innerportion 3603 shown above the first lumen 3612, the second aperture 3640b may expose a portion of the inner portion 3603 shown between the firstlumen 3612 and the second lumen 3613, the third aperture 3640 c mayexpose a portion of the inner portion 3603 shown below the second lumen3613, or combinations thereof. In other embodiments, more or fewerportions of the inner portion 3603 may be exposed. In the presentembodiment, at least one of the apertures 3640 a, 3640 b, 3640 c mayextend from the proximal end to the distal end. In other embodiments,the apertures 3640 a, 3640 b, 3640 c may extend between but notincluding both the proximal end and the distal end. The apertures 3640a, 3640 c may extend from an outer surface 3607 of the outer portion3605 to an outer surface 3641 of the inner portion 3603.

The lumens 3612, 3613 are shown in FIG. 33 in an unexpanded state. Thelumens 3612, 3613 may include first inner dimensions 3612 a, 3613 a,respectively. The first inner dimensions 3612 a, 3613 a may include adiameter, a cross-sectional area, a radius, an arc length, otherdimensions, or combinations thereof. For example, the first innerdimension 3613 a of the second lumen 3613 may be a diameter of about sixFrench in an unexpanded state.

The inner portion 3603 may include a first material that may include atleast one relatively expandable material. The first material may providelubricious properties to facilitate medical devices being insertedand/or removed through the lumen 3612. For example, the first materialmay include ePTFE, which may provide both expandability and lubricity.

The outer portion 3605 may include a second material that may provideexpandability and/or lubricity. For example, the second material mayinclude an elastomeric material. In the present embodiment, the secondmaterial may be less expandable (i.e. may have a lower modulus ofelasticity) than the first material of the inner portion 3603. Inembodiments where the second material may be less expandable than thefirst material and despite the reduced expandability of the secondmaterial, the exposure of the inner portion 3603 through at least aportion of the outer portion 3605 may facilitate expansion of the innerportion 3603. A less expandable second material may increase thelongitudinal strength (i.e. resistance to buckling in the longitudinaldirection) and/or pushability of the introducer sheath while providingradial expandability of the introducer sheath through the moreexpandable first material.

The tubular portion 3604, the inner portion 3603, the outer portion3605, the first lumen 3612, the second lumen 3613, the first aperture3640 a, the second aperture 3640 b, the third aperture 3640 c, othercomponents of the introducer sheath (such as introducer sheath 3400shown in FIG. 30), or combinations thereof, may increase in at least onedimension in the expanded state. The inner portion 3603 and the outerportion 3605 may expand in conjunction with the first lumen 3612 and/orthe second lumen 3613. The apertures 3640 a, 3640 b, 3640 c may expandcircumferentially. Expansion of the apertures 3640 a, 3640 b, 3640 c mayincrease the size of at least one of the exposed portions of the innerportion 3603 of the tubular portion 3604. The outer portion 3605 may bedisposed around less of the inner portion 3603 in the expanded state.

The lumens 3612, 3613 may include second inner dimensions (not shown) inan expanded state. The second inner dimensions may include a diameter, across-sectional area, a radius, an arc length, other dimensions, orcombinations thereof. For example, the second inner dimension of thesecond lumen 3613 may include a diameter of about ten French. The secondlumen 3613 may expand from the first inner dimension 3613 a to a secondinner dimension (not shown) of the second lumen 3613. This expansion maybe about sixty-five percent. For example, from about six French to aboutten French. In other embodiments, the expansion may be more and/or lessthan about sixty-five percent. For example, it may be as little as aboutten percent. The first inner dimension 3612 a of the first lumen 3612may expand in similar fashion.

The inner portion 3603 and/or the outer portion 3605 may be arranged tofacilitate entry and/or exit of a medical device through the lumens3612, 3613 by expanding to accommodate the medical device withoutcreating further apertures (not shown) in the outer surface (not shown)of the tubular portion 3604.

FIG. 34 illustrates a perspective view of a further embodiment of anintroducer sheath 3700. The introducer sheath 3700 of the embodimentdescribed herein and shown in FIG. 33 may be functionally similar to theintroducer sheaths and/or tubular portions described herein in mostrespects, wherein certain features may not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this embodimentdescribed below. Like structures and/or components are given likereference numerals.

The elongate or tubular portion 3704 may extend between a proximal end3718 and a distal end 3720. The tubular portion 3704 may include aninner portion 3703 and an outer portion 3705. The inner portion 3703and/or the outer portion 3705 may extend between the proximal end 3718and the distal end 3720 of the tubular portion 3704.

In the present embodiment, the inner portion 3703 may form a lumen 3712.In other embodiments, the inner portion 3703 may form a plurality oflumens. The lumen 3712 may include an entry portion, such as entryportion 2228 shown in FIG. 18. The outer portion 3705 may be disposedpartially around the inner portion 3703. For example, at least a portionof the inner portion 3703 may be exposed between the proximal end andthe distal end of the tubular portion 3704. In the present embodiment,multiple portions of the inner portion 3703 may be exposed.

The tubular portion 3704 may include at least one aperture. In thepresent embodiment, the tubular portion 3704 may include a firstaperture 3740 a, a second aperture 3740 b, a third aperture 3740 c, afourth aperture 3740 d, a fifth aperture 3740 e, and a sixth aperture3740 f. The apertures 3740 a, 3740 b, 3740 c, 3740 d, 3740 e, 3740 f mayexpose at least a portion of the inner portion 3703 between the proximalend 3718 and the distal end 3720 of the tubular portion 3704.

The apertures 3740 a, 3740 b, 3740 c, 3740 d, 3740 e, 3740 f may exposevarious portions of the inner portion 3703. The apertures 3740 a, 3740b, 3740 c, 3740 d, 3740 e, 3740 f may be longitudinally and/or axiallyoriented with respect to the lumen 3712 and/or circumferentiallyoriented with respect to the proximal end 3718 and/or the distal end3720 of the tubular portion 3704.

For example and as shown in FIG. 34, the first aperture 3740 a mayexpose a portion of the inner portion 3703 from the proximal end 3718toward the distal end 3720, the second aperture 3740 b may expose aportion of the inner portion 3703 longitudinally and circumferentiallyoffset from the first aperture 3740 a, the third aperture 3740 c mayexpose a portion of the inner portion 3703 longitudinally andcircumferentially offset from the first aperture 3740 and the secondaperture 3740 b, the fourth aperture 3740 d may expose a portion of theinner portion 3703 longitudinally but not circumferentially offset fromthe third aperture 3740 c, the fifth aperture 3740 e may expose aportion of the inner portion 3703 longitudinally and circumferentiallyoffset from the third aperture 3740 c and circumferentially but notlongitudinally offset from the fourth aperture 3740 d, and the sixthaperture 3740 f may expose a portion of the inner portion 3703longitudinally but not circumferentially offset from the second aperture3740 b with a larger longitudinal offset from the second aperture 3740 bthan the third aperture 3740 c though still longitudinally offset fromthe distal end 3720, such that nearly the entire length of the tubularportion 3704 may be exposed from the proximal end 3718 to the distal end3720. In other embodiments, more or fewer portions of the inner portion3703 may be exposed using more or fewer apertures in varyinglongitudinal and/or circumferential offsets and/or axial orientationswith respect to the proximal end 3718, the distal end 3720, otherapertures, or combinations thereof. In the present embodiment, none ofthe apertures 3740 a, 3740 b, 3740 c, 3740 d, 3740 e, 3740 f extend fromthe proximal end 3718 to the distal end 3720. In other embodiments, atleast one of the apertures 3740 a, 3740 b, 3740 c, 3740 d, 3740 e, 3740f may extend from the proximal end to the distal end. The apertures 3740a, 3740 b, 3740 c, 3740 d, 3740 e, 3740 f may extend from an outersurface 3707 of the outer portion 3705 to an outer surface 3741 of theinner portion 3703.

The inner portion 3703 may include a first material that may include atleast one relatively expandable material. The first material may providelubricious properties to facilitate medical devices being insertedand/or removed through the lumen 3712. For example, the first materialmay include ePTFE, which may provide both expandability and lubricity.

The outer portion 3705 may include a second material that may provideexpandability and/or lubricity. For example, the second material mayinclude an elastomeric material. In the present embodiment, the secondmaterial may be less expandable (i.e. may have a lower modulus ofelasticity) than the first material of the inner portion 3703. Inembodiments where the second material may be less expandable than thefirst material and despite the reduced expandability of the secondmaterial, the exposure of the inner portion 3703 through at least aportion of the outer portion 3705 may facilitate expansion of the innerportion 3703. A less expandable second material may increase thelongitudinal strength (i.e. resistance to buckling in the longitudinaldirection) and/or pushability of the introducer sheath while providingradial expandability of the introducer sheath through the moreexpandable first material.

The inner portion 3703 and/or the outer portion 3705 may be arranged tofacilitate entry and/or exit of a medical device through the lumen 3712by expanding to accommodate the medical device without creating furtherapertures (not shown) in the outer surface (not shown) of the tubularportion 3704.

FIG. 35 illustrates a perspective view of yet another embodiment of anintroducer sheath. The introducer sheath 3800 of the embodimentdescribed herein and shown in FIG. 35 may be functionally similar to theintroducer sheaths and/or tubular portions described herein in mostrespects, wherein certain features may not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this embodimentdescribed below. Like structures and/or components are given likereference numerals.

The introducer sheath 3800 may include a hub portion 3802. The hubportion 3802 may include a flange 3801. The hub portion 3802 and/or theflange 3801 May configured to selectively connect to a medical device(not shown) to limit longitudinal and/or axial motion of the introducersheath 3800 with respect to the medical device.

The elongate or tubular portion 3804 may extend between a proximal end3818 and a distal end 3820. The tubular portion 3804 may include atleast one inner portion 3803 a, 3803 b and an outer portion 3805. Theinner portions 3803 a, 3803 b and/or the outer portion 3805 may extendbetween the proximal end 3818 and the distal end 3820 of the tubularportion 3804.

In the present embodiment, the inner portion 1003 may form at least twolumens 3812, 3813. In other embodiments, the inner portions 3803 a, 3803b may form more or fewer lumens. The outer portion 3805 may be disposedat least partially around the inner portions 3803 a, 3803 b. Forexample, at least a portion of at least one inner portion 3803 a, 3803 bmay be exposed between the proximal end and the distal end of thetubular portion 3804. In other embodiments, multiple portions of themore or fewer inner portions may be exposed. For example in someembodiments, it may be desirable for a lumen, such as lumen 3812 to beless expandable than another lumen, such as lumen 3813 such that noportion or fewer portions of the inner portion, such as inner portion3803 a, may be exposed.

The tubular portion 3804 may include an aperture 3840. The aperture 3840may be longitudinally and/or axially oriented with respect to the lumen1012 and/or circumferentially oriented with respect to the proximal end3818 and/or the distal end 3820 of the tubular portion 3804. In thepresent embodiment, the aperture 3840 may expose a portion of the innerportions 3803 a, 3803 b from the proximal end 3818 to the distal end3820 in a generally helical manner. The axial orientation (i.e. pitch)of the aperture 3840 may be constant and/or vary along the length of thetubular portion 3804.

In other embodiments, more or fewer portions of the inner portions 3803a, 3803 b may be exposed using more or fewer apertures in varyinglongitudinal and/or circumferential offsets and/or axial orientationswith respect to the proximal end 3818, the distal end 3820, otherapertures, or combinations thereof. In the present embodiment, theaperture 3840 extends from the proximal end 3818 to the distal end 3820.The aperture 3840 may extend from an outer surface (not shown) of theouter portion 3805 to an outer surface (not shown) of the inner portions3803 a, 3803 b.

The inner portions 3803 a, 3803 b may include a first material. Thefirst material may include at least one relatively expandable material.The first material may provide lubricious properties to facilitatemedical devices being inserted and/or removed through the lumen 3812.For example, the first material may include ePTFE, which may provideboth expandability and lubricity. The present embodiment, the innerportions 3803 a, 3803 b may include the same first material. In otherembodiments, the inner portions 3803 a, 3803 b may include differentmaterials.

The outer portion 3805 may include a second material. The secondmaterial may provide expandability and/or lubricity. For example, thesecond material may include an elastomeric material. In the presentembodiment, the second material may be less expandable (i.e. may have alower modulus of elasticity) than the first material of the innerportions 3803 a, 3803 b. In embodiments where the second material may beless expandable than the first material and despite the reducedexpandability of the second material, the exposure of the inner portions3803 a, 3803 b through at least a portion of the outer portion 3805 mayfacilitate expansion of the inner portions 3803 a, 3803 b. A lessexpandable second material may increase the longitudinal strength (i.e.resistance to buckling in the longitudinal direction) and/or pushabilityof the introducer sheath while providing radial expandability of theintroducer sheath through the more expandable first material.

The first inner portion 3803 a, the second inner portion 3803 b, theouter portion 3805, or combinations thereof may be arranged tofacilitate entry and/or exit of a medical device through the lumen 3812by expanding to accommodate the medical device without creating furtherapertures (not shown) in the outer surface (not shown) of the tubularportion 3804.

The various introducer sheaths described herein that include an innerportion and an outer portion may be manufactured by forming the innerportion and forming the outer portion around the inner portion such thatthe outer portion encloses less than the entirety of the outer surfaceof the inner portion between the proximal end and a distal end. Thetubular portion and/or hub portion of an introducer sheath may bemanufactured using various processes. For example, the tubular portionand/or hub portion of an introducer sheath may be manufactured using aninjection molding process, an overmolding process, an extrusion process,a coextrusion process, a bump extrusion process, other processes, orcombinations thereof.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. An introducer sheath comprising: a tubular bodyextending from a distal end toward a proximal end, the body comprising:a lumen defined at least partially by a wall; a secondary channeldefined at least partially by the wall configured to receive aguidewire; a portion of the wall forming an expandable portion, theexpandable portion configured to increase a cross-sectional area of thebody, the expandable portion being located between the lumen and thesecondary channel; and an outer portion at least partially surroundingthe wall, the outer portion comprising a first aperture exposing a firstportion of the wall adjacent the lumen and a second aperture exposing asecond portion of the wall adjacent the secondary channel, the firstaperture and the second aperture being on opposite sides of the tubularbody along a first transverse axis that is transverse to a longitudinalaxis of the tubular body, an intermediate portion of the outer portion,between the first aperture and the second aperture in the direction,extends toward the expandable portion on both sides of the expandableportion along a second transverse axis that is transverse to thelongitudinal axis of the tubular body, a distance between ends of theintermediate portion adjacent the expandable portion increasing as theexpandable portion increases the cross-sectional area of the body alongthe second transverse axis.
 2. The introducer sheath of claim 1, whereinthe expandable portion comprises a first material including an elastomerand the outer portion comprises a second material.
 3. The introducersheath of claim 1, wherein the tubular body further comprises an entryportion at the distal end, the entry portion facilitating entry of amedical device, and the tubular body being configured to expand toaccommodate the medical device without splitting an outer surface of thetubular body.
 4. An introducer sheath, comprising: a hub portionextending from a distal end toward a proximal end, the hub portionhaving a hub lumen formed therein; and a tubular body extending from adistal end toward a proximal end, the tubular body comprising: a lumendefined at least partially by a wall; a secondary channel defined atleast partially by the wall and configured to receive a guidewire; aportion of the wall forming an expandable portion configured to increasea cross-sectional area of the tubular body, the expandable portionlocated between the lumen and the secondary channel; and an outerportion at least partially surrounding the wall between the lumen andthe secondary channel, the outer portion comprising first and secondapertures on opposite sides of the tubular body in along a firsttransverse axis that is transverse to a longitudinal axis of the tubularbody and an intermediate portion, between the first and second aperturesin the direction, receiving a portion of the wall at a location wherethe outer portion extends toward the expandable portion on both sides ofthe expandable portion along a second transverse axis that is transverseto the longitudinal axis, the first and second apertures and theintermediate portion increase in at least one dimension in an expandedstate of the tubular body, a distance between ends of the intermediateportion adjacent the expandable portion increasing as the expandableportion increases the cross-sectional area of the body along the secondtransverse axis.
 5. The introducer sheath of claim 4, wherein thetubular body further comprises an entry portion at the distal end, theentry portion facilitating entry of a medical device without splittingan outer surface of the tubular body.
 6. A method for introducing amedical device into a body, the method comprising: positioning a sheathupon a guidewire disposed within a body lumen, the sheath comprising atubular body extending from a distal end toward a proximal end, thetubular body comprising a lumen defined at least partially by a wall, asecondary channel being defined at least partially by the wall andconfigured to receive the guidewire, and an expandable portion formed bya portion of the wall, the expandable portion configured to increase across-sectional area of the tubular body, the expandable portion locatedbetween the lumen and the secondary channel, and an outer portion atleast partially surrounding the wall, the outer portion comprising afirst aperture exposing a first portion of the wall adjacent the lumenand a second aperture exposing a second portion of the wall adjacent thesecondary channel, the first aperture and the second aperture being onopposite sides of the tubular body along a first transverse axis that istransverse to a longitudinal axis of the tubular body, an intermediateportion of the outer portion, between the first aperture and the secondaperture in the direction, extends toward the expandable portion on bothsides of the expandable portion along a second transverse axis that istransverse to the longitudinal axis of the tubular body, a distancebetween ends of the intermediate portion adjacent the expandable portionincreasing as the expandable portion increases the cross-sectional areaof the body along the second transverse axis; introducing the sheathinto the body lumen; selectively inserting one or more medical devicesinto the body lumen through the sheath; and upon selectively insertingone or more medical devices into the body lumen through the sheath,expanding a cross-section of one or more of the lumen or the secondchannel and pivoting portions of the outer portion about theintermediate portion when the lumen and the secondary channel transitionfrom an unexpanded state to an expanded state.
 7. The method of claim 6,wherein the expandable portions is located near an inner wall of thelumen and/or on an inner wall of the secondary channel.